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
Nicardipine Hydrochloride Injection (2.5mg/mL)
Class IIFailed Impurities/Degradation Specifications: Out of specification for organic impurities
Eugia US LLC · Feb 20, 2024
Moxifloxacin 5mg/ml
Class IIPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC DBA Leiters Health · Feb 20, 2024
Nicardipine Hydrochloride Injection
Class IIFailed Impurities/Degradation Specifications: Out of specification for organic impurities
Eugia US LLC · Feb 20, 2024
Clindamycin Phosphate
Class IIIDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contract Pharmaceuticals Limited Canada · Feb 20, 2024
7 Eleven FOR GAS ISLAND USE ONLY
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
7 Eleven Hand Sanitizer Gel
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
PROBLEND Hand Sanitizer
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
PROBLEND E3 Foaming Hand Sanitizer
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
Broncochem Cold & Tea (acetaminophen
Class IIStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Global Corporation · Feb 16, 2024
Broncochem Cold & Flu Syrup Kids (acetaminophen
Class IIStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Global Corporation · Feb 16, 2024
Methocarbamol Injection
Class IPresence of Particulate Matter
Eugia US LLC · Feb 15, 2024
Fluticasone Propionate Nasal Spray USP
Class IICGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Golden State Medical Supply Inc. · Feb 14, 2024
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Class IIFailed Impurities/Degradation Specifications: Out-of-specification test results.
Amneal Pharmaceuticals of New York, LLC · Feb 13, 2024
Clobazam Tablets 10mg
Class IICGMP Deviations: Out of specification for residual solvents.
Micro Labs Limited · Feb 12, 2024
ForeverMen Natural Energy Boost Capsules
Class IMarketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
FA Online Inc · Feb 12, 2024
CABTREO (clindamycin phosphate
Class IICGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
MCKESSON CORPORATION · Feb 12, 2024
Fluticasone Propionate Nasal Spray USP 50mcg
Class IICGMP Deviations: potential presence of Burkholderia cepacia complex
Apotex Corp. · Feb 9, 2024
Telmisartan Tablets
Class IIFailed Stability Specifications: Out of specification for blend uniformity.
Micro Labs Limited · Feb 9, 2024
HydrALAZINE Hydrochloride Tablets
Class IIan out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Feb 9, 2024
Mercaptopurine Tablets
Class IIIFailed Dissolution Specifications: results slightly under spec at at 9-months.
Stason Pharmaceuticals, Inc. · Feb 9, 2024
Infuvite Adult Multiple vitamins injection
Class IIcGMP Deviations: Products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office · Feb 7, 2024
Rocuronium Bromide Injection
Class IIcGMP Deviations: Products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office · Feb 7, 2024
Bicillin L-A (Penicillin G Benzathine) 1.2
Class IIcGMP Deviations: Products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office · Feb 7, 2024
Sustain Herbal Dietary Supplement
Class IMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World · Feb 6, 2024
SCHWINNNG Herbal Dietary Supplement
Class IMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World · Feb 6, 2024
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/…
Class IIcGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Mallinckrodt Hospital Products Inc. · Feb 6, 2024
Arize Herbal Dietary Supplement
Class IMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World · Feb 6, 2024
Terlivaz (terlipressin for injection)
Class IIcGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Mallinckrodt Hospital Products Inc. · Feb 6, 2024
Voriconazole for Oral Suspension
Class IILabeling: Incorrect or Missing Package Insert
Lupin Pharmaceuticals Inc. · Feb 5, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Super Chill Products · Feb 5, 2024
Mesalamine Extended-Release Capsules
Class IIFailed Dissolution Specifications: Out of specification for dissolution.
SUN PHARMACEUTICAL INDUSTRIES INC · Feb 5, 2024
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Class IISubpotent Drug: Out of specification for assay
Bausch Health Companies, Inc. · Feb 2, 2024
To the Moon Capsules
Class IMarketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Integrity Products · Feb 1, 2024
HydrALAZINE Hydrochloride Tablets
Class IIIFailed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Amerisource Health Services LLC · Feb 1, 2024
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box…
Class IMarketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Integrity Products · Feb 1, 2024
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Class IChemical Contamination; presence of benzene.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Feb 1, 2024
Lansoprazole Delayed-Release Capsules USP
Class IICGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
NATCO Pharma Limited · Feb 1, 2024
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%
Class IILack of Assurance of Sterility
Brassica Pharma Pvt Ltd · Jan 30, 2024
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%)
Class IILack of Assurance of Sterility
Brassica Pharma Pvt Ltd · Jan 30, 2024
Showing 40 of 1,769 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.