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
Carvedilol Tablets USP
Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Aug 20, 2025
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL)
Class IIDiscoloration
Baxter Healthcare Corporation · Aug 20, 2025
Dextroamphetamine Saccharate
Class IIPresence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Lannett Company Inc. · Aug 19, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
chlorproMAZINE Hydrochloride Tablets
Class IIPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Amneal Pharmaceuticals, LLC · Aug 18, 2025
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Class IITemperature Abuse
Sandoz Inc · Aug 13, 2025
Tavaborole Topical Solution 5%
Class IIDiscoloration
VIONA PHARMACEUTICALS INC · Aug 12, 2025
Lisdexamfetamine Dimesylate Capsules
Class IILabeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Lannett Company Inc. · Aug 11, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc. · Aug 8, 2025
Theophylline extended-release tablets 400mg
Class IIFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Glenmark Pharmaceuticals Inc., USA · Aug 8, 2025
Carvedilol Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals Inc., USA · Aug 7, 2025
Carvedilol Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals Inc., USA · Aug 7, 2025
Carvedilol Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Glenmark Pharmaceuticals Inc., USA · Aug 7, 2025
Metoprolol Tartrate Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Westminster Pharmaceuticals LLC · Aug 6, 2025
Metoprolol Tartrate Tablets
Class IICGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Westminster Pharmaceuticals LLC · Aug 6, 2025
Carvedilol Tablets
Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Glenmark Pharmaceuticals Inc., USA · Aug 6, 2025
Carvedilol Tablets
Class IICGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Glenmark Pharmaceuticals Inc., USA · Aug 6, 2025
Spironolactone Tablets
Class IIPresence of foreign substance: identified as aluminum.
SUN PHARMACEUTICAL INDUSTRIES INC · Aug 5, 2025
Enoxaparin Sodium Injection
Class IICorrect Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Cardinal Health Inc. · Aug 5, 2025
Vial Label: 8.4% Sodium Bicarbonate Injection
Class IILack of Assurance of Sterility.
PFIZER INC · Aug 4, 2025
Vial Label: Epinephrine Injection
Class IILack of Assurance of Sterility.
PFIZER INC · Aug 4, 2025
Lactated Ringer's Injection USP
Class IILack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
B BRAUN MEDICAL INC · Aug 4, 2025
0.9% Sodium Chloride Injection USP
Class IILack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
B BRAUN MEDICAL INC · Aug 4, 2025
Ultra Burn for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Semaglutide with B12 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Xolair (omalizumab injection)
Class IICGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
Sterile Saline Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
B6 (Pyridoxine HCl) for Injections
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Sermorelin Lyophilized powder for reconstitution
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
BPC-157/Thymosin Beta-4 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Low Solubility Peptide Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
L-Arginine HCl for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Thymosin Beta-4 (TB4) for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Ascorbic Acid (Vitamin C) for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Zinc Chloride for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Xolair (omalizumab injection)
Class IICGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
4.2% Sodium Bicarbonate Injection
Class IIFailed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Exela Pharma Sciences LLC · Jul 30, 2025
Showing 40 of 1,472 Class II recalls (1,769 tracked in total).
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.