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
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 units/mL)
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…
Class IMarketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Integrity Products · Feb 1, 2024
TING 1% Tolnaftate Athlete's Foot Spray Antifungal 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
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
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic…
Class IIIDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc · Jan 25, 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
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35
Class IIIDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc · 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 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
Equate Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Kroger Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Meijer Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
CVS Health Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Fexofenadine Hydrochloride Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Zolpidem Tartrate Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Febuxostat Tablets 40mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Glimepiride Tablets
Class IIIMisprint on tablet
Dr. Reddy's Laboratories, Inc. · Jan 18, 2024
Febuxostat Tablets 80 mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Lurasidone Hydrochloride Tablets 120mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Cinacalcet Tablets 60mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Mesalamine Delayed-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Glimepiride Tablets
Class IIIMisprint on tablet
Dr. Reddy's Laboratories, Inc. · Jan 18, 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.