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
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone)
Class IIMicrobial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Brands International Corporation · Jun 10, 2024
Allopurinol Tablets
Class IIPresence of foreign substance.
Dr. Reddy's Laboratories, Inc. · Jun 7, 2024
STELLALIFE VEGA Oral Care
Class IMicrobial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Homeocare Laboratories, Inc. · Jun 5, 2024
STELLALIFE ADVANCED FORMULA Peppermint
Class IIMicrobial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Homeocare Laboratories, Inc. · Jun 5, 2024
Amoxicillin and Clavulanate Potassium Tablets USP
Class IISubpotent Drug
Teva Pharmaceuticals USA, Inc · Jun 4, 2024
Eszopiclone Tablets
Class IIIFailed Impurities/Degradation Specifications: Related Substances
Dr. Reddy's Laboratories, Inc. · Jun 4, 2024
Phenazopyridine HCl
Class IIProduct Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
RemedyRepack Inc. · May 31, 2024
Complete 30C/200C Homeopathic Kit
Class IIILabeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Washington Homeopathic Products, Inc. · May 31, 2024
Potassium Chloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Potassium Chloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size)
Class IIFailed Content Uniformity Specifications
Lupin Pharmaceuticals Inc. · May 30, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · May 28, 2024
Little Remedies Gas Relief Drops (Simethicone/Antigas)
Class IIcGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Denison Pharmaceuticals, LLC · May 28, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
Petroleum Jelly
Class IILabeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Consumer Product Partners, LLC · May 28, 2024
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · May 28, 2024
Phenazopyridine HCl Tablets USP
Class IIProduct Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Winder Laboratories, LLC · May 28, 2024
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad…
Class IMicrobial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
SYNCHRONICITY SPA INC, DBA SUNTE · May 24, 2024
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple…
Class IICGMP Deviations
SYNCHRONICITY SPA INC, DBA SUNTE · May 24, 2024
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Class IILack of Assurance of Sterility: Leaking vials
Dr. Reddy's Laboratories, Inc. · May 23, 2024
Dexamethasone Sodium Phosphate injection USP
Class IIFailed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Eugia US LLC · May 23, 2024
Eptifibatide injection 20mg/10mL (2mg/mL)
Class IIIFailed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Eugia US LLC · May 22, 2024
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Class IIMarketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
MexHealth LLC · May 22, 2024
Extra Strength Acetaminophen 500 MG Tablets
Class IIDiscoloration: Brownish tablets
Contract Pharmacal Corporation · May 20, 2024
Buprenorphine Hydrochloride Injection
Class IILack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc. · May 20, 2024
Labetalol Hydrochloride Injection
Class IILack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc. · May 20, 2024
Cathflo activase (ALTEPLASE)
Class IILack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Genentech, Inc. · May 20, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · May 17, 2024
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension
Class IIILabeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
GlaxoSmithKline LLC · May 17, 2024
Estradiol Transdermal System
Class IIIFailed Impurities/Degradation Specifications.
Zydus Pharmaceuticals (USA) Inc · May 16, 2024
Pregabalin Capsules 50mg
Class IIIPresence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Rising Pharma Holding, Inc. · May 16, 2024
Estradiol Transdermal System
Class IIIFailed Impurities/Degradation Specifications.
Zydus Pharmaceuticals (USA) Inc · May 16, 2024
EYLEA, (aflibercept) Injection, For Intravitreal 2 mg (0.05mL of a 40mg/mL…
Class IILack of Assurance of Sterility: Complaints of syringe breakage
Regeneron Pharmaceuticals Inc · May 15, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 Preservative-Free 1mL Single-Use…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1%…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Showing 40 of 1,903 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.