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
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
Everolimus tablets 2.5 mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · 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
Everolimus tablets 7.5mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · 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
Karina Daily Moisturizer SPF 25
Class IICGMP Deviations
CA BOTANA International, Inc. · Oct 10, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Breckenridge Pharmaceutical, Inc. · Oct 9, 2025
FentaNYL Citrate PF
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 9, 2025
Hydromorphone HCL PF
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 9, 2025
Sucralfate Tablets
Class IICGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Amerisource Health Services LLC · Oct 9, 2025
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Class IIFailed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
USV Private Limited · Oct 9, 2025
Taoscare Motion Sickness Patches 36-count box
Class IIMarketed Without an Approved NDA/ANDA
ibspot · Oct 9, 2025
Ketamine Hydrochloride
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 9, 2025
Fasenra (benralizumab) Injection
Class IILack of Assurance of Sterility:
ASTRAZENECA PHARMACEUTICALS · Oct 8, 2025
Mojo Max Fusion XXX
Class IMarketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Mohamed Hagar · Oct 8, 2025
Prazosin Hydrochloride
Class IICGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Teva Pharmaceuticals USA, Inc · Oct 7, 2025
Prazosin Hydrochloride
Class IICGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Teva Pharmaceuticals USA, Inc · Oct 7, 2025
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle,…
Class IIProduct mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Rising Pharma Holding, Inc. · Oct 7, 2025
Prazosin Hydrochloride
Class IICGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Teva Pharmaceuticals USA, Inc · Oct 7, 2025
Desipramine Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc · Oct 6, 2025
Desipramine Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc · Oct 6, 2025
Desipramine Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc · Oct 6, 2025
Desipramine Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc · Oct 6, 2025
Desipramine Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc · Oct 6, 2025
Desipramine Hydrochloride Tablets
Class IICGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc · Oct 6, 2025
Tavaborole Topical solution 5%
Class IIDiscoloration
VIONA PHARMACEUTICALS INC · Oct 6, 2025
TESTO-100 CIII (testosterone 100 mg)
Class IILack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Advanced Pharmaceutical Technology, Inc. · Oct 3, 2025
Ketorolac Tromethamine Injection
Class IIPresence of Particulate Matter: Particulate matter identified as glass
Aspiro Pharma Limited · Oct 1, 2025
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR
Class IILabeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Church & Dwight Co., Inc. · Oct 1, 2025
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alco…
Class IIcGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Acuity Specialty Products, Inc. · Sep 29, 2025
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per bo…
Class IISubpotent Drug
Medline Industries, LP · Sep 29, 2025
Showing 40 of 1,769 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.