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
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
Clonazepam Orally Disintegrating Tablet
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Endo USA, Inc. · Nov 18, 2024
ZoomMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
PeakMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
VitalityXtra Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
ZapMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
Ascorbic Acid Inj. Solution
Class IPresence of Particulate Matter: Presence of glass particulates.
Staska Pharmaceuticals, Inc. · Sep 30, 2024
Veklury (remdesivir) for injection
Class IPresence of Particulate Matter: Presence of glass particle.
Gilead Sciences, Inc. · Sep 19, 2024
Vail-Bon Jie Yang Wan capsules
Class IMarketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
123Herbals · Sep 18, 2024
Atovaquone Oral Suspension
Class IMicrobial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Bionpharma Inc. · Sep 17, 2024
Heparin Sodium in 0.9% Chloride Injection)
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Baxter Healthcare Corporation · Aug 1, 2024
0.9% Sodium Chloride Injection USP
Class IPresence of Particulate Matter
B. Braun Medical Inc · Jul 24, 2024
Umary Acido Hialuronico
Class IMarketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
MAIN PRODUCTS INC · Jul 18, 2024
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Class IMarketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Supercore Products Group Inc. · Jul 12, 2024
Umary Acido Hialuronico
Class IMarketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
SoloVital · Jul 12, 2024
Gold Hard Steel Plus Liquid
Class IMarketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Supercore Products Group Inc. · Jul 12, 2024
Healthy Living Acetaminophen
Class ILabeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Aurobindo Pharma USA Inc · Jul 11, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Endo Pharmaceuticals, Inc. · Jul 10, 2024
Acetaminophen Injection
Class ILabeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Hikma Pharmaceuticals USA Inc. · Jul 8, 2024
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Amerisource Health Services LLC · Jun 25, 2024
Acetaminophen Extra Strength Tablets
Class ILabeling: 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.
A-S Medication Solutions LLC · Jun 21, 2024
STELLALIFE VEGA Oral Care
Class IMicrobial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Homeocare Laboratories, Inc. · Jun 5, 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
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · 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
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
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Class ILabeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Hikma Injectables USA Inc · Apr 29, 2024
Schwinnng Herbal Dietary Supplement Capsules
Class IMarketed Without An Approved NDA/ANDA
Stop Clopez Corp · Apr 22, 2024
Tirzepatide 10 mg/0.5 mL Sterile Solution
Class ILabeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Revive Rx LLC dba Revive Rx Pharmacy · Apr 20, 2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg
Class ISub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc. · Apr 8, 2024
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Class ISub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc. · Apr 8, 2024
Atovaquone Oral Suspension USP
Class IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.
AvKARE · Mar 28, 2024
Aruba Aloe Hand Sanitizer Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Alcoholada Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Vancomycin Hydrochloride for Oral Solution
Class ISuperpotent Drug: Due to overfilling of drug powder
Amneal Pharmaceuticals of New York, LLC · Mar 21, 2024
GoHARD 25000
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
libigrow RED DRAGON+
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Showing 40 of 143 Class I recalls (1,895 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.