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
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) B…
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 sa…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate…
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) T…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, N…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, N…
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%, N…
Class IICGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED · Apr 24, 2025
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: P…
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, N…
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%, N…
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
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Artificial Tears Ophthalmic Solution
Class IIcGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC · Apr 23, 2025
Clindamycin HCl Capsule
Class IICGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
RemedyRePack Inc. · Apr 22, 2025
PROLIA (denosumab)
Class IICGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office · Apr 21, 2025
BENLYSTA (belimumab) for injection
Class IICGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office · Apr 21, 2025
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL)
Class IIOut-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLC · Apr 21, 2025
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only…
Class IICGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office · Apr 21, 2025
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL)
Class IIOut-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLC · Apr 21, 2025
Clindamycin Hydrochloride Capsules
Class IIcGMP Deviations
Preferred Pharmaceuticals, Inc. · Apr 18, 2025
niCARdipine Hydrochloride Injection
Class IILack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc. · Apr 18, 2025
niCARdipine Hydrochloride Injection
Class IILack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc. · Apr 18, 2025
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.