FDA Recall
TerminatedTerminated: May 15, 2024Historical recordClass II
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 15, 2024Historical recordClass II
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
by Pine Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 29, 2025Historical recordClass I
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
by KVK-Tech, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 22, 2025Historical recordClass II
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
by Baxter Healthcare Corporation
- Reason
- CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 30, 2024Historical recordClass I
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
by VistaPharm LLC
- Reason
- Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628
by Church & Dwight Inc
- Reason
- Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
by Dollar Tree Distribution, Inc.
- Reason
- CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 2, 2024Historical recordClass III
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 17, 2025Historical recordClass III
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
by Imprimis NJOF, LLC
- Reason
- Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
CompletedHistorical recordClass II
HEINZ
- Product
- Kraft Singles American Pasteurized Prepared Cheese product,…
- Reason
- Plastic fragment. Product is recalled due to potential for a thin strip of the primary packaging film to remain adhered to the cheese slice after the wrapper has been removed.
- Published
- October 25, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Moody Dunbar Inc
- Product
- Sweet Potatoes sold under the brand names: HEB CUT SWEET POT…
- Reason
- During an internal investigation, the firm noticed that the Retort Chart was malfunctioning. No data was recorded during the production run.
- Published
- October 25, 2023
- Distribution
- Product was shipped to Florida, Texas an…
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FDA Recall
CompletedHistorical recordClass I
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
by Scynexis, Inc.
- Reason
- Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
- Published
- October 18, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 10, 2024Historical recordClass II
Infinant Health, LLC
- Product
- Evivo with MCT Oil Infant Probiotic Activated B. infantis EV…
- Reason
- Unapproved food additive.
- Published
- October 18, 2023
- Distribution
- U.S. Distribution to the following: TX,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 10, 2024Historical recordClass II
Maisie Jane's California Sunshine Products Inc.
- Product
- Maisie Jane's Smooth almond butter, 12 oz glass jar, 6 units…
- Reason
- High levels of aflatoxin
- Published
- October 18, 2023
- Distribution
- The product is distributed throughout th…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 22, 2024Historical recordClass II
Fairfield Gourmet Food Corp d/b/a David's Cookies
- Product
- Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g),…
- Reason
- Fairfield Gourmet Food Corp. d/b/a David s Cookies ,28 Industrial Road, Fairfield NJ 07004has initiated a recall of Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g) plastic package (i.e.) Clamp shell 8 package per case, LOT # BS23212 (Manufactured on July, 31, 2023) because of MISLABELED / UNDECLARED ALLERGENS (Peanuts)
- Published
- October 18, 2023
- Distribution
- The recall product was distributed to th…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 2, 2023Historical recordClass II
The Little Oak Company Ltd
- Product
- LittleOak Natural Goat Milk Follow On Infant Formula (Stage…
- Reason
- No pre-market notification and Mixing instructions not in ounces
- Published
- October 18, 2023
- Distribution
- WY, CA, NY, GA, IL, UT, MD, CO, PA, VT,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 2, 2023Historical recordClass II
The Little Oak Company Ltd
- Product
- LittleOak Natural Goat Milk Infant Formula (Stage 1); packag…
- Reason
- No pre-market notification and Mixing instructions not in ounces
- Published
- October 18, 2023
- Distribution
- WY, CA, NY, GA, IL, UT, MD, CO, PA, VT,…
View recall →
FDA Recall
OngoingHistorical recordClass II
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.
by Eugia US LLC
- Reason
- Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 21, 2025Historical recordClass III
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979
by Imprimis NJOF, LLC
- Reason
- Subpotent: Failing Test Results for Epinephrine
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2024Historical recordClass III
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
by Amerisource Health Services LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
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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