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
Moxifloxacin PF
Class IIPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC DBA Leiters Health · Feb 20, 2024
Lidocaine HCL 1% (10mg/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
Methylprednisolone acetate Injectable Suspension
Class IIFailed Dissolution Specifications
Eugia US LLC · Feb 20, 2024
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
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
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
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
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
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
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
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
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
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient
Class IILack of Assurance of Sterility
Brassica Pharma Pvt Ltd · Jan 30, 2024
Equate Lubricant Eye Ointment (Mineral Oil 42.5%
Class IILack of Assurance of Sterility
Brassica Pharma Pvt Ltd · Jan 30, 2024
Pure Care Foaming Mint Hand Sanitizer 62%
Class IICGMP Deviations
Alpha Aromatics · Jan 25, 2024
Febuxostat Tablets
Class IICGMP Deviations
Amerisource Health Services LLC · Jan 25, 2024
Norepinephrine Bitartrate in 5% Dextrose Injection
Class IIIncorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Baxter Healthcare Corporation · Jan 23, 2024
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Class IISub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
IntegraDose Compounding Services LLC · Jan 22, 2024
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Class IICGMP Deviations
OMEZA LLC · Jan 19, 2024
Omeza Skin Protectant
Class IICGMP Deviations
OMEZA LLC · Jan 19, 2024
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.