FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
Fluphenazine HCl Elixir
Class IIFailed Stability Specifications
Safecor Health, LLC · Aug 13, 2026
Fluphenazine HCl Elixir
Class IIFailed Stability Specifications
Safecor Health, LLC · Aug 13, 2026
Fluphenazine HCl Elixir
Class IIFailed Stability Specifications
Safecor Health, LLC · Aug 13, 2026
Fluphenazine HCl Elixir
Class IIFailed Stability Specifications
Safecor Health, LLC · Aug 13, 2026
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx…
Class IIFailed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Apotex Corp. · Aug 13, 2026
Lactated Ringer's Injection USP
Class IPresence of Particulate matter.
B BRAUN MEDICAL INC · Aug 12, 2026
Epinephrine Injection
Class IPresence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
American Regent, Inc. · Aug 11, 2026
Tyenne (tocilizumab-aazg) Injection
Class IPresence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Fresenius Kabi USA, LLC · Aug 10, 2026
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus…
Class IICGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Church & Dwight Co., Inc. · Aug 10, 2026
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++
Class IIcGMP Deviations
SHANTOU Qiwei industrial Co., Ltd · Aug 8, 2026
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Class IIIPresence of Foreign Tablets/Capsules
Bionpharma Inc. · Aug 7, 2026
Carbamazepine Tablets
Class IICGMP deviations: tablets with black specks.
Golden State Medical Supply Inc. · Aug 7, 2026
Clindamycin Phosphate in 0.9% Sodium Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vancomycin Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vancomycin Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Famotidine Injection in Sodium Chloride
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Nexterone (amiodarone HCI)
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), mg…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Pantoprazole Sodium in 0.9% Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL)…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2…
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Clindamycin Injection USP in 5% Dextrose
Class IICGMP Deviations
Baxter Healthcare Corporation · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Acthar Gel (repository corticotropin injection)
Class IIPresence of particulate matter: glass and stopper piece
Mallinckrodt Hospital Products Inc. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Aug 6, 2026
Showing 40 of 1,895 recalls tracked.
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.