FDA Recall
🇺🇸 United States
TerminatedTerminated: April 11, 2025Historical recordClass I
Prime Food Processing Corp.
- Product
- Prime Food brand Steam Bun with Egg Custard Added; 10pcs/pac…
- Reason
- Products may contain undeclared sesame
- Published
- September 4, 2024
- Distribution
- AZ, CA, CO, CT, FL, GA, HI, IL, KS, KY,…
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FDA Recall
OngoingHistorical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
by FDC Limited
- Reason
- Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210
by Zeco LLC
- Reason
- CGMP Deviations: sterile water not used for production
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
by Zeco LLC
- Reason
- CGMP Deviations: sterile water not used for production
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
by Teva Pharmaceuticals USA, Inc
- Reason
- Superpotent Drug
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
by Fagron Compounding Services
- Reason
- Lack of Assurance of Sterility
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 14, 2025Historical recordClass II
Refresco Beverages US Inc
- Product
- Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged…
- Reason
- Product contains inorganic arsenic above action level set in industry guidance (13.2ppb)
- Published
- August 28, 2024
- Distribution
- Retail locations in: AL, CT, DC, DE, FL,…
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FDA Recall
OngoingHistorical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
by FDC Limited
- Reason
- Defective container; yellow colored spike from cap lodged in the nozzle
- Published
- August 21, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 20, 2024Historical recordClass I
North Fish USA, Inc.
- Product
- Cold Smoked Capelin, 9-ounce packages, plastic trays, 34 pac…
- Reason
- Clostridium botulinum (uneviscerated fish)
- Published
- August 21, 2024
- Distribution
- U.S. distribution to the following: GA a…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 13, 2024Historical recordClass I
Foppen Paling En Zalm B.V.
- Product
- Foppen Smoked Norwegian Salmon Slices - Toast Size, packaged…
- Reason
- Potential contamination with Listeria monocytogenes
- Published
- August 21, 2024
- Distribution
- AL, AR, GA, IL, IN, KY, LA, MI, MO, MS,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 30, 2024Historical recordClass I
Publix Super Markets, Inc.
- Product
- Boars Head Grab and Go Wedge Ham, Smoke Master Black Forest…
- Reason
- Potential Listeria Monocytogenes
- Published
- August 21, 2024
- Distribution
- U.S. Distribution within the states in r…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 23, 2026Historical recordClass II
G.S. Gelato and Desserts Inc.
- Product
- FULL CIRCLE market COCONUTMILK CHOCOLATE ALMOND CRUNCH NON0D…
- Reason
- Undeclared cashews. The firm was notified by a customer that the top label and the carton labels do not match. The carton label states, "coconut milk" while the top label states, "cashew milk". The product actually contains the cashew milk product.
- Published
- August 21, 2024
- Distribution
- The product was shipped to the following…
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FDA Recall
TerminatedTerminated: June 12, 2025Historical recordClass II
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
by Granules Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
- Published
- August 14, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 7, 2025Historical recordClass I
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
by A-S Medication Solutions LLC
- Reason
- Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
- Published
- August 14, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 28, 2025Historical recordClass II
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
by EMPOWER CLINIC SERVICES LLC
- Reason
- Lack of Assurance of Sterility
- Published
- August 14, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass III
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
by Amneal Pharmaceuticals, LLC
- Reason
- Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
- Published
- August 14, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 28, 2025Historical recordClass III
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
by Novel Laboratories, Inc. d.b.a Lupin Somerset
- Reason
- Defective container: potential for non-sealed pouches which can lead to product leakage.
- Published
- August 14, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
by MAIN PRODUCTS INC
- Reason
- Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
- Published
- August 14, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
by Dr. Reddy's Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- Published
- August 14, 2024
- Distribution
- Nationwide
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Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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