FDA AnnouncementPar Health USA, LLC
Argatroban Injection 250 mg/2.5 mL (100 mg/mL)
Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel
Announced October 14, 2026
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FDA AnnouncementPar Health
Brevital Sodium 500 mg/vial for Injection
Presence of particulate matter identified as cellulose
Announced October 9, 2026
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FDA AnnouncementGreenwich Rx
Glutathione Injection
Potential elevated endotoxin levels
Announced October 1, 2026
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FDA AnnouncementOtsuka ICU Medical LLC
0.9% Sodium Chloride Injection, USP, 100 mL
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
Announced September 21, 2026
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FDA AnnouncementPar Health
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Presence of particulate matter identified as cellulose or stopper material
Announced September 21, 2026
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FDA AnnouncementCentric Compounding LLC
Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune Boost 30 mL multidose vial
Elevated Endotoxin level
Announced September 13, 2026
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FDA AnnouncementB. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Presence of particulate matter identified as iron oxide
Announced September 3, 2026
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FDA AnnouncementAna Salazar Modela Tu Cuerpo Inc.
Lipofit Extreme 2.0 Fat Burner Dietary Supplement
Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Announced August 31, 2026
· View FDA announcement
FDA AnnouncementBaxter International Inc.
0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container
Potential presence of particulate matter identified as fiberglass in the solution.
Announced August 26, 2026
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FDA AnnouncementBaxter International Inc.
70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container
Potential presence of particulate matter identified as stainless steel particles in the solution.
Announced August 25, 2026
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FDA AnnouncementBaxter International Inc.
Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container
Potential presence of particulate matter identified as fiberglass in the solution
Announced August 25, 2026
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FDA AnnouncementVitruvias Therapeutics, Inc
Thyroid Tablets, USP 30 mg
Potential for the Product to be Superpotent
Announced August 24, 2026
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FDA AnnouncementOptimal Balance Pharmacy
Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial
Elevated Endotoxin level
Announced August 20, 2026
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FDA AnnouncementB. Braun
Excel® Lactated Ringers Injection, 1000mL
Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene
Announced August 19, 2026
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FDA AnnouncementFresenius Kabi
Tyenne Injection 400 mg/20 mL vial
Due to Presence of Glass Particles
Announced August 11, 2026
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FDA AnnouncementFresenius Kabi
Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
Due to a label mix-up
Announced August 5, 2026
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FDA AnnouncementVictory Medical Center Pharmacy
Compounded Glutathione 200 mg/mL Multi-Dose Vials
Elevated Endotoxin level
Announced August 5, 2026
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FDA AnnouncementLiebel-Flarsheim Company, LLC
OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Announced August 4, 2026
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FDA AnnouncementAmerican Regent, Inc. Animal Health
Adequan Canine Injection and Adequan i.m Injection for horses
Visible glass fiber material in the product
Announced August 3, 2026
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FDA AnnouncementAmerican Regent, Inc.
Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Products were found to contain particulate matter
Announced July 27, 2026
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FDA AnnouncementSunny Pharmtech, Inc.
Cyclophosphamide for Injection
Presence of particulate matter identified as steel
Announced July 24, 2026
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FDA AnnouncementBaxter International Inc.
Cefazolin in Dextrose Injection
Particulate matter (cardboard) found in the solution.
Announced July 24, 2026
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FDA AnnouncementUnique Pharmaceutical Laboratories
Cetirizine Hydrochloride Tablets USP 5 mg
Potential cross contamination with Ranitidine
Announced July 20, 2026
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FDA AnnouncementBeekeeper’s Naturals
Saline Nasal Spray
Above acceptable microbiological limits for yeast and may contain Aspergillus spp.
Announced June 12, 2026
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FDA AnnouncementBD
ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators
Potential fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
Announced June 8, 2026
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FDA AnnouncementHaleon
Gass-X Extra Strength Softgels 120 and 72ct
Potential chemical contamination
Announced June 4, 2026
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FDA AnnouncementSun Pharmaceutical Industries, Inc.
DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Presence of glass particles
Announced May 13, 2026
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FDA AnnouncementPharmacal
Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube
Contaminated with Staphylococcus aureus.
Announced May 12, 2026
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FDA AnnouncementB. Braun Medical Inc.
Lactated Ringer's Injection, E7500, 1L
Products were found to contain particulate matter in solution
Announced April 28, 2026
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FDA AnnouncementBlaine Labs, Inc.
Antiseptic wound care gel bottles and tubes
Products were found to contain Lysinibacillus fusiformis, an environmental organism
Announced April 8, 2026
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FDA AnnouncementAphreseller
Dietary supplement capsules marketed for treatment for gaining weight and stimulating appetite.
Device & Drug Safety/Unapproved Drug
Announced April 1, 2026
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FDA AnnouncementAmneal Pharmaceuticals LLC
Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag
A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL.
Announced March 24, 2026
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FDA AnnouncementCardinal Health
Large Alcohol Prep Pads (70% isopropyl alcohol)
Microbial Contamination
Announced March 20, 2026
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FDA AnnouncementAnthony Trinh, 123Herbals LLC
Dietary supplement capsules marketed for relief of joint and body aches
Unapproved new drug found to contain undeclared meloxicam
Announced January 9, 2026
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FDA AnnouncementModern Warrior
Dietary supplement capsules marketed for metabolism moosting, improving brain function, and reducing cravings
Unapproved new drug found to contain undeclared 1,4-DMAA and aniracetam, and tianeptine
Announced January 9, 2026
· View FDA announcement
FDA AnnouncementGold Star Distribution, Inc.
All FDA-regulated products held at facility including drugs, medical devices, cosmetics, dietary supplements, human food, and pet food
Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process.
Announced December 26, 2025
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FDA AnnouncementHandelnine Global Limited d/b/a Navafresh
Rheumacare Capsules
Elevated levels of lead
Announced December 22, 2025
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FDA AnnouncementStuffbyNainax LLC
Dietary supplement for male enhancement
Undeclared Sildenafil and Tadalafil
Announced December 16, 2025
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FDA AnnouncementMediNatura New Mexico Inc.
Nasal spray, 0.68 fl oz
Product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.
Announced December 16, 2025
· View FDA announcement
FDA AnnouncementMediNatura New Mexico Inc.
Nasal spray, 0.68 fl oz
Product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.
Announced December 10, 2025
· View FDA announcement
FDA AnnouncementFresenius Kabi USA, LLC
Famotidine Injection, USP 20 mg per 2 mL
Out-of-specification endotoxin results
Announced November 7, 2025
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FDA AnnouncementOtsuka ICU Medical LLC
20 mEq Potassium Chloride Injection
Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection
Announced November 3, 2025
· View FDA announcement
FDA AnnouncementGreen Lumber Holding, LLC.
Dietary Supplement
Undeclared prescription drug-Tadalafil
Announced August 29, 2025
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FDA AnnouncementDermaRite Industries
Hand Sanitizers, Cleansers, Skin Protectants, Deodorant
Device & Drug Safety - Potential Burkholderia cepacia contamination
Announced August 28, 2025
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FDA AnnouncementUnichem Pharmaceuticals
Cyclobenzaprine Hydrochloride Tablets USP 10 mg
Device & Drug Safety – Mislabel
Announced August 27, 2025
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FDA AnnouncementB. Braun Medical, Inc.
Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL
Due to the presence of particulate matter.
Announced August 19, 2025
· View FDA announcement
FDA AnnouncementDermaRite Industries, LL
OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers
Contamination with Burkholderia cepacia
Announced August 9, 2025
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FDA AnnouncementNostrum Laboratories, Inc.
Sucralfate Tablets USP 1 gram
Company closure and discontinuation of quality activities.
Announced July 14, 2025
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FDA AnnouncementSandoz Inc.
Cefazolin for Injection, USP, 1 gm vial
Potential Presence of Penicillin G Potassium Injection Vial
Announced June 27, 2025
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FDA AnnouncementChurch & Dwight Co., Inc.
Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs
Microbial contamination
Announced June 6, 2025
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FDA AnnouncementAmneal Pharmaceutical LLC
Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg
Microbial contamination
Announced June 4, 2025
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FDA AnnouncementUMARY USA
Unavy Acidio Hialuronico (30 caplets/850 mg) and Umovy Acidio Hialuronico (30 caplets/850 mg)
The product contains undeclared Dexamethasone, Diclofenac and Omeprazole
Announced May 22, 2025
· View FDA announcement
FDA AnnouncementEnShiShiXiangNiShangMaoYouXianGongSi
Dietary supplement for male performance and energy
Undeclared Propoxyphenylsildenafil, Sildenafil
Announced May 6, 2025
· View FDA announcement
FDA AnnouncementAmneal Pharmaceuticals LLC.
Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag
Product may contain an inert fiber identified as polypropylene fibers from the IV bag
Announced April 18, 2025
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FDA AnnouncementCAPS
Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag
Due to visible black particulate matter
Announced February 25, 2025
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FDA AnnouncementAscent Consumer Products Inc.
Soft Tip Squeeze Bottle Nasal Wash System
Microbial contamination of the product with Staphylococcus aureus (S. aureus)
Announced February 25, 2025
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FDA AnnouncementOne Source Nutrition
Vitality male enhancement dietary supplement capsules
Undeclared Sildenafil and Tadalafil
Announced February 20, 2025
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FDA AnnouncementBD
ChloraPrep Clear 1 mL applicator skin preparation product
Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
Announced February 18, 2025
· View FDA announcement
FDA AnnouncementICU Medical
POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq
Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.
Announced February 14, 2025
· View FDA announcement
FDA AnnouncementAlvogen, Inc.
Fentanyl Transdermal System 25 mcg/h transdermal patches
There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch
Announced January 31, 2025
· View FDA announcement
FDA AnnouncementProvepharm Inc.
Phenylephrine hydrochloride Injection, USP, 10 mg/ mL
Device & Drug Safety – Potential Foreign Material
Announced January 24, 2025
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FDA AnnouncementAstellas Pharma US, Inc.
Tacrolimus and Tacrolimus Extended-Release capsules
Bottles may contain empty capsules.
Announced December 24, 2024
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FDA AnnouncementAlcon Laboratories
Lubricant Eye Drugs
Due to Fungal Contamination
Announced December 23, 2024
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FDA AnnouncementEndo, Inc.
Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)
Product is an unapproved drug.
Announced December 20, 2024
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FDA AnnouncementShoppers-Plaza
SugarLin Herbal Formula Herbal Dietary Supplement
Product contains undeclared Metformin and Glyburide
Announced December 18, 2024
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FDA AnnouncementBuy-herbal.com
Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules
Device & Drug Safety – Unapproved Drug
Announced December 13, 2024
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FDA AnnouncementMXBBB
UMARY Hyaluronic Acid tablets
The product contains undeclared diclofenac and omeprazole
Announced November 21, 2024
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FDA AnnouncementTerminatedEndo, Inc.
Clonazepam Orally Disintegrating Tablets, USP (C-IV)
Mislabeled with the incorrect strength on the carton
Announced November 19, 2024
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FDA AnnouncementVitalityVita
Marketed as Dietary Supplement
Undeclared Sildenafil and Diclofenac
Announced November 6, 2024
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FDA AnnouncementBoulla LLC
Marketed as Dietary Supplement
Undeclared Sildenafil and Diclofenac
Announced November 5, 2024
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FDA AnnouncementC&A Naturistics
AK Forte Dietary Supplement
Device & Drug Safety – Unapproved Drug
Announced October 16, 2024
· View FDA announcement
FDA AnnouncementSTASKA Pharmaceuticals Inc.
Ascorbic Acid Solution for Injection
Device & Drug Safety – Presence of glass particulates
Announced October 16, 2024
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FDA AnnouncementTerminatedGilead Sciences, Inc.
Veklury (remdesivir) for Injection
Due to Presence of Glass Particle
Announced September 23, 2024
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FDA AnnouncementBionpharma Inc.
Atovaquone Oral Suspension, 750 mg/mL
Product found to be contaminated with Cohnella bacteria
Announced September 18, 2024
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FDA AnnouncementB. Braun Medical Inc.
0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers
Potential for particulate matter and fluid leakage of the containers
Announced August 8, 2024
· View FDA announcement
FDA AnnouncementBaxter International Inc
Heparin Sodium in 0.9% Sodium Chloride Injection
Elevated endotoxin levels
Announced August 6, 2024
· View FDA announcement
FDA AnnouncementAurobindo Pharma USA, Inc.
Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets
Device & Drug Safety - Mislabeling
Announced July 24, 2024
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FDA AnnouncementMain Products, Inc.
Umary Acido Hialuronico, Suplemento Alimenticio
Undeclared Drug Ingredients: Diclofenac and Omeprazole
Announced July 22, 2024
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FDA AnnouncementHikma Pharmaceuticals PLC
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL
Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).
Announced July 22, 2024
· View FDA announcement
FDA AnnouncementEndo USA, Inc
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets
Mislabeled with the incorrect strength on the carton
Announced July 17, 2024
· View FDA announcement
FDA AnnouncementGuru Inc.
Infla-650 Herbal Dietary Supplement Capsules
Tainted with the drug ingredients: acetaminophen, diclofenac and phenylbutazone
Announced July 16, 2024
· View FDA announcement
FDA AnnouncementSoloVital.com
Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg
Tainted with the drug ingredients, diclofenac and omeprazole
Announced July 15, 2024
· View FDA announcement
FDA AnnouncementAmerican Health Packaging
Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count
Failed dissolution
Announced June 26, 2024
· View FDA announcement
FDA AnnouncementGlenmark Pharmaceuticals, Inc.
Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count
Failed dissolution
Announced June 25, 2024
· View FDA announcement
FDA AnnouncementSuntegrity Skincare
Sunscreen foundation
Higher than acceptable microbiological mold count
Announced June 12, 2024
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FDA AnnouncementIntegrity Products
Dietary Supplements for Male Sexual Enhancement
Product is tainted with sildenafil and tadalafil
Announced June 11, 2024
· View FDA announcement
FDA AnnouncementHomeoCare Laboratories Inc.
Homeopathic StellaLife Oral Care Products
Microbial contamination
Announced June 5, 2024
· View FDA announcement
FDA AnnouncementSagent Pharmaceuticals
Docetaxel Injection, USP
Potential presence of particulate matter
Announced May 29, 2024
· View FDA announcement
FDA AnnouncementHospira Inc.
Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units
Device & Drug Safety – Potential Packaging Defect
Announced May 22, 2024
· View FDA announcement
FDA AnnouncementSTOP CLOPEZ CORP
Herbal Dietary Supplement
Product is tainted with Nortadalafil
Announced April 23, 2024
· View FDA announcement
FDA AnnouncementDr. Reddy’s Laboratories Inc
Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
Decreased Potency
Announced April 23, 2024
· View FDA announcement
FDA AnnouncementAruba Aloe Balm N.V.
Hand Sanitizer Gel and Alcoholada Gel
Product contains methanol
Announced April 5, 2024
· View FDA announcement
FDA AnnouncementHoneywell Safety Products USA
Non-Sterile Eyewash Cartridge
Non-compliance with current good manufacturing practice (cGMP) requirements.
Announced April 5, 2024
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FDA AnnouncementAvKARE, LLC
Atovaquone Oral Suspension, USP 750mg/5mL
Potential Bacillus cereus contamination
Announced April 1, 2024
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FDA AnnouncementEugia US LLC
Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Device & Drug Safety – Presence of Particulate Matter
Announced March 28, 2024
· View FDA announcement
FDA AnnouncementTerminatedAmneal Pharmaceuticals, LLC.
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Super potent due to bottles being overfilled
Announced March 27, 2024
· View FDA announcement
FDA AnnouncementPyramid Wholesale
Dietary supplements for sexual enhancement
Undeclared Sildenafil and/or Tadalafil
Announced March 20, 2024
· View FDA announcement
FDA AnnouncementEndo International, Par Pharmaceutical
Treprostinil 20mg/20mL Injection
Potential Presence of Silicone Particulate Matter
Announced March 12, 2024
· View FDA announcement
FDA AnnouncementBrassica Pharma Pvt. Ltd.
Eye ointment products
Due to Potential Lack of Sterility Assurance.
Announced February 26, 2024
· View FDA announcement
FDA AnnouncementToday the World
Sustain and Schwinnng brand male enhancement capsules
Products contain undeclared Tadalafil and Nortadalafil
Announced February 5, 2024
· View FDA announcement
FDA AnnouncementToday the World
Arize brand male enhancement capsules
Products contain undeclared Nortadalafil
Announced February 5, 2024
· View FDA announcement
FDA AnnouncementInsight Pharmaceuticals
1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid
Presence of benzene
Announced February 2, 2024
· View FDA announcement
FDA AnnouncementNeptune Resources, LLC
Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets
Undeclared Tianeptine
Announced January 29, 2024
· View FDA announcement
FDA AnnouncementTerminatedAzurity Pharmaceuticals, Inc.
dextroamphetamine sulfate tablets, 30 mg
Mislabeled package
Announced January 25, 2024
· View FDA announcement
FDA AnnouncementTerminatedHaleon
Cough syrups
Microbial Contamination
Announced January 24, 2024
· View FDA announcement
FDA AnnouncementKilitch Healthcare India Limited
Lubricant Eye Drops & Multi-Symptom Eye Drops
Device & Drug Safety Potential Safety Concerns
Announced January 22, 2024
· View FDA announcement
FDA AnnouncementLeiters Health
Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
Potential for superpotent drug
Announced January 8, 2024
· View FDA announcement
FDA AnnouncementKilitch Healthcare India Limited
Lubricant Eye Drops & Multi-Symptom Eye Drops
Device & Drug Safety Potential Safety Concerns
Announced November 15, 2023
· View FDA announcement
FDA AnnouncementTerminatedThe Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
OTC Ophthalmic Sterile Drops
Insanitary manufacturing conditions
Announced November 1, 2023
· View FDA announcement
FDA AnnouncementTerminatedKVK-Tech, Inc.
Betaxolol Tablets, USP
Potential Presence of Oxycodone HCl tablet
Announced October 3, 2023
· View FDA announcement
FDA AnnouncementTerminatedHospira, Inc.
4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP
Potential Presence of Glass Particulates
Announced October 2, 2023
· View FDA announcement
FDA AnnouncementTerminatedVistaPharm
Sucralfate Oral Suspension 1g/10mL
Potential contamination with Bacillus cereus
Announced September 22, 2023
· View FDA announcement
FDA AnnouncementMerck Animal Health
Banamine; Banamine-S
Potential presence of particulate matter
Announced September 1, 2023
· View FDA announcement
FDA AnnouncementTerminatedMarlex Pharmaceuticals, Inc.
Digoxin Tablets USP, 0.125mg and 0.25mg
Label Mix-Up
Announced August 31, 2023
· View FDA announcement
FDA AnnouncementTerminatedLupin Pharmaceuticals, Inc.
Tydemy oral contraceptive
Out of Specification Results
Announced July 31, 2023
· View FDA announcement
FDA AnnouncementTerminatedCipla
Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)
Failure to deliver the recommended dose
Announced July 7, 2023
· View FDA announcement
FDA AnnouncementTerminatedThe Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories
Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg
Packaging may contain incorrect product due to labeling mix-up
Announced June 14, 2023
· View FDA announcement
FDA AnnouncementTerminatedJarman’s Midwest Cleaning Systems, Inc.
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution
Due to Presence of Methanol
Announced March 28, 2023
· View FDA announcement
FDA AnnouncementTerminatedVolt Candy
PrimeZEN Black 6000 male enhancement capsules
Product contains undeclared tadalafil and sildenafil
Announced February 13, 2023
· View FDA announcement
FDA AnnouncementTerminatedEdgewell Personal Care
Hair & Scalp Spray SPF 30
Due to presence of benzene
Announced January 30, 2023
· View FDA announcement
FDA AnnouncementTerminatedSpectrum Laboratory Products Inc.
Epinephrine bulk API
Product discoloration
Announced January 9, 2023
· View FDA announcement
FDA AnnouncementTerminatedGFA Production
After Burn® Cream and First Aid Kits containing After Burn Cream
Product is contaminated with Bacillus licheniformis and Bacillus sonorensis.
Announced December 27, 2022
· View FDA announcement
FDA AnnouncementTerminatedLupin Pharmaceuticals Inc.
Quinapril 20 and 40 mg tablets
Presence of nitrosamine impurity, N-Nitroso-Quinapril
Announced December 21, 2022
· View FDA announcement
FDA AnnouncementTerminatedMylan Institutional LLC, a Viatris company
Octreotide Acetate Injection, 500 mcg/mL
Due to glass particulates
Announced October 25, 2022
· View FDA announcement
FDA AnnouncementTerminatedGolden State Medical Supply, Incorporated
Clopidogrel 75mg Tablets, Atenolol 25mg Tablets
Due to Label Mix-up
Announced September 29, 2022
· View FDA announcement
FDA AnnouncementTerminatedSalon Technologies International Inc.
Ocean Citron Hand Sanitizer
Product contains benzene
Announced September 19, 2022
· View FDA announcement
FDA AnnouncementFamily Dollar
Toothpaste
Product was stored outside of labeled temperature requirements
Announced September 16, 2022
· View FDA announcement
FDA AnnouncementTerminatedHospira, Inc., a Pfizer Company
Propofol Injection Emulsion, USP
Potential presence of visible particulate
Announced August 22, 2022
· View FDA announcement
FDA AnnouncementTerminatedBryant Ranch Prepack Inc.
Morphine Sulfate 30 mg Extended-Release tablets
Incorrect labeling
Announced June 29, 2022
· View FDA announcement
FDA AnnouncementTerminatedPlastikon Healthcare, LLC
Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
Due to microbial contamination
Announced June 8, 2022
· View FDA announcement
FDA AnnouncementTerminatedPfizer
Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Due to N-Nitroso-Quinapril Content
Announced April 22, 2022
· View FDA announcement
FDA AnnouncementFamily Dollar, Inc.
Numerous human food, animal (pet) food, medical devices, and drug products
Potential Salmonella contamination and presence of rodent activity at the distribution center
Announced February 18, 2022
· View FDA announcement
FDA AnnouncementTerminatedAuroMedics Pharma LLC
Polymyxin B for Injection USP, 500,000 Units/Vial
Presence of Particulate Matter
Announced January 28, 2022
· View FDA announcement
FDA AnnouncementTerminatedMylan Pharmaceutical Inc.
Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens
Missing Label
Announced January 19, 2022
· View FDA announcement
FDA AnnouncementTerminatedThe Proctor & Gamble Company
Old Spice and Secret Aerosol Sprays
Due to the presence of benzene
Announced November 23, 2021
· View FDA announcement
FDA AnnouncementEli Lilly and Company
Glucagon Emergency Kit
Loss of potency
Announced September 26, 2021
· View FDA announcement
FDA AnnouncementPfizer
Varenicline tablets
N-nitroso-varenicline above acceptable daily intake level
Announced September 16, 2021
· View FDA announcement
FDA AnnouncementPfizer
Smoking cessation treatment
N-Nitroso Varenicline content above ADI level
Announced July 19, 2021
· View FDA announcement
FDA AnnouncementS&B Shopper LLC
Dietary Supplement for Male Enhancement
Undeclared Sildenafil & Tadalafil
Announced March 25, 2021
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FDA AnnouncementTerminatedPrecision Dose Inc.
Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups
Potential contamination with Burkholderia lata
Announced December 31, 2020
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FDA AnnouncementTerminatedMarksans Pharma Limited
Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg
Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Announced October 5, 2020
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FDA AnnouncementTerminatedAshtel Studios
Hand sanitizer packaged in 0.84 oz. pouches
Product is packaged in containers resembling a food and drink pouch
Announced October 2, 2020
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FDA AnnouncementEstado de México, México, DMM VISSION, S.A. de C.V
Cleaner Hand Sanitizer
Potential Presence of Methanol (Wood Alcohol)
Announced September 30, 2020
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FDA AnnouncementTerminatedSun Pharmaceutical Industries
Metformin Hydrochloride for Extended-Release Oral Suspension
Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Announced September 23, 2020
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FDA AnnouncementOpen Book Extracts
Hand Sanitizer
Products labeled to contain methanol
Announced August 31, 2020
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FDA AnnouncementHARMONIC NATURE S. DE R.L. Mi
Hand sanitizer
Product contains 1 propanol
Announced August 28, 2020
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FDA AnnouncementTerminatedNanomateriales, SA de CV
Hand sanitizer
Product contains 1-propanol.
Announced August 26, 2020
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FDA AnnouncementTerminatedAsiaticon SA de CV
Hand Sanitizer
Potential presence of methanol (wood alcohol) and subpotent ethanol levels
Announced August 25, 2020
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FDA AnnouncementBayshore Pharmaceuticals, LLC
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg
Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Announced August 20, 2020
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FDA AnnouncementGrupo Asimex de Mexico SA de CV
Antiseptic Hand Sanitizer, 70% Alcohol
Potential Methanol Contamination
Announced August 20, 2020
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FDA AnnouncementALBEK de Mexico S.A. de C.V.
Hand Sanitizer
Undeclared Methanol
Announced August 18, 2020
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FDA AnnouncementTerminatedGrupo Yacana México S.A.S de C.V.
Yacana Hand Sanitizer, 70% Alcohol
Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol
Announced August 18, 2020
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FDA AnnouncementTerminatedSG24 LLC
All Day Hand Sanitizer
Contains Methanol
Announced August 15, 2020
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FDA AnnouncementSoluciones Cosmeticas
Hand Sanitizer Gel
Potential Methanol Contamination
Announced August 9, 2020
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FDA AnnouncementTerminatedIncredible Products Sa de Cv
Antibacterial Handgel
Methanol Contamination
Announced August 7, 2020
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FDA AnnouncementTerminatedRoque Plast S.A. de C.V.
Hand Sanitizer
Methanol Contamination
Announced August 4, 2020
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FDA AnnouncementTerminatedLaboratorios Jaloma S.A. de C.V.
Hand Sanitizer
Undeclared Methanol
Announced August 1, 2020
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FDA AnnouncementTerminatedBroncolin S.A. de C.V
Hand Sanitizer
Undeclared Methanol
Announced July 28, 2020
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FDA AnnouncementResource Recovery & Trading, LLC
Hand Sanitizer
Undeclared Methanol subpotency ethyl alcohol
Announced July 27, 2020
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FDA Announcement4e Brands North America
Hand Sanitizer
Undeclared Methanol
Announced July 27, 2020
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FDA AnnouncementTerminatedMaquiladora Miniara, S.A. de C.V.
Hand Sanitizer Gel
Potential presence of methanol (wood alcohol)
Announced July 24, 2020
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FDA AnnouncementTerminatedReal Clean Distribuciones SA de CV
Hand Sanitizer
Undeclared methanol
Announced July 24, 2020
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FDA AnnouncementTerminatedLIQ-E S.A. de C.V.
Hand Sanitizer
Potential Methanol Contamination
Announced July 20, 2020
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FDA AnnouncementTerminatedSoluciones Cosmeticas
Hand Sanitizer Gel
Potential Methanol Contamination
Announced July 14, 2020
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FDA AnnouncementTerminatedAAA Cosmetica, S.A. de C.V.
Hand Sanitizer
Potential Undeclared Methanol Contamination
Announced July 14, 2020
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FDA Announcement4e Brands North America
Hand Sanitizer
Undeclared Methanol
Announced July 13, 2020
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FDA AnnouncementTerminatedLupin Pharmaceuticals, Inc.
Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg
N-Nitrosodimethylamine (NDMA) Impurity
Announced July 8, 2020
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FDA AnnouncementTerminatedITECH 361
Hand sanitizer
Potential presence of methanol (wood alcohol).
Announced July 6, 2020
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FDA AnnouncementTerminatedTransliquid Technologies LLC
Mystic Shield Protection Topical Solution
Undeclared methanol
Announced July 2, 2020
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FDA AnnouncementTerminatedUVT, INC.
Advanced Hand Sanitizer, 70% alcohol content
Potential presence of methanol (wood alcohol)
Announced June 29, 2020
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FDA AnnouncementSaniderm Products
Advanced Hand Sanitizer
May contain methanol (wood alcohol)
Announced June 27, 2020
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FDA AnnouncementTeva Pharmaceuticals USA Inc.
Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Due to detection of N-Nitrosodimethylamine (NDMA)
Announced June 5, 2020
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FDA AnnouncementTerminatedGL Holdings
Dietary supplements for male sexual enhancement
Contains Tadalafil
Announced October 22, 2019
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FDA AnnouncementTerminatedTeva Pharmaceuticals USA, Inc.
Losartan potassium tablets
Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
Announced June 11, 2019
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FDA AnnouncementVivimed
Losartan Potassium Tablets USP
Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
Announced May 3, 2019
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FDA AnnouncementAsclemed USA Inc dba Envoachem Pharmeceuticals
Dyural-40 and Dyural-80
Due to Latex Hazard
Announced December 17, 2018
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FDA AnnouncementBD
Vacutainer tubes
Inaccurate lead test results
Announced March 22, 2018
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FDA AnnouncementTerminatedUltra Shop Supplement
Dietary Supplement
Unapproved new drug
Announced February 8, 2018
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FDA AnnouncementKiriko, LLC
Dietary Supplement A1 Slim
Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine
Announced October 19, 2017
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