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
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
Phentermine Hydrochloride Capsules
Class IIcGMP deviations
KVK Tech, Inc. · May 9, 2025
Celecoxib Capsules
Class IIPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Alembic Pharmaceuticals Limited · May 9, 2025
Indomethacin Extended-Release Capsules USP
Class IIcGMP deviations
KVK Tech, Inc. · May 9, 2025
Chlorthalidone Tablets
Class IIFailed Dissolution Specifications
AvKARE · May 9, 2025
Bromfenac Ophthalmic Solution 0.09%
Class IIFailed Impurities/Degradation Specifications
Alembic Pharmaceuticals Limited · May 7, 2025
ENDURANCE BOOST WITH HORNY GOAT WEED
Class IMarketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
EnShiShiXiangNiShangMaoYouXianGongSi · May 6, 2025
Testosterone Cypionate Injection
Class IILack of Assurance of Sterility
Empower Clinic Services, LLC dba Empower Pharmacy · May 2, 2025
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%)
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 28, 2025
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%)
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 28, 2025
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%)
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 28, 2025
TESTOSTERONE PELLET 200 mg BLUNT
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 28, 2025
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%)
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 28, 2025
temper tamer
Class IICGMP Deviations
Siddha Flower Essences, LLC. · Apr 28, 2025
Medroxyprogesterone Acetate Injectable Suspension
Class IISevere thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Mckesson Medical-Surgical Inc. Corporate Office · Apr 25, 2025
Infuvite Adult
Class IISevere thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Mckesson Medical-Surgical Inc. Corporate Office · Apr 25, 2025
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL)…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Cinnafresh anticavity gel toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
KOFAL Original
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g)…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Maximum Security
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Maximum Security
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Rapidol Maximum Strength
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15%
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Maximum Security Anticavity Gel Toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Maximum Security
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint Anticavity Fluoride Toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint Anticavity Fluoride Toothpaste
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Lubricant Eye Drops Solution
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Showing 40 of 1,895 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.