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
Tirzepatide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Testosterone 87.5 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone Regular Release 200 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 200 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide 50MG/10MCG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone Regular Release 50 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG)
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 25MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG)
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 62.5 MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone 50MG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Testosterone / Triamcinolone Acetonide 25MG/5MCG
Class IICGMP Deviations: Potential presence of metal particulate matter
FARMAKEIO OUTSOURCING LLC · Oct 14, 2025
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Class IISubpotent drug; Clavulanate Potassium component
Teva Pharmaceuticals USA, Inc · Oct 13, 2025
Dr. Bump Natural Pain Relief Gel
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Gabriel Mineral Sunscreen SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Elixir by Coco March Mineral Sunscreen SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
R.E.C.K. (Ropivacaine HCl
Class IIPresence of Particulate Matter
QuVa Pharma, Inc. · Oct 10, 2025
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Doctor D. Schwab Clinical Weh Natural Pain Relief Gel with Menthol and Arnica
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Gabapentin Capsules
Class IIFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
The Harvard Drug Group LLC · Oct 10, 2025
CLEARSTEM YOU ARE SUNSHINE SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Doctor. D. Schwab Mineral Sunscreen SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Doctor D. Schwab Controlling Balm with Tea Tree Oil
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
HADLIMA (adalimumab-bwwd) injection
Class IILack of Assurance of Sterility.
Samsung Bioepis Co., Ltd. · Oct 10, 2025
Doctor D. Schwab Controlling Cream
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Gabapentin Capsules
Class IIFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
The Harvard Drug Group LLC · Oct 10, 2025
Niacin Extended-release Tablets
Class IIFailed Dissolution Specifications
Lannett Company Inc. · Oct 10, 2025
Haloperidol Lactate Injection
Class IILabeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Safecor Health, LLC · Oct 10, 2025
Elixir by Coco March Tinted Mineral Sunscreen SPF 50
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Showing 40 of 1,576 Class II recalls (1,895 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.