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
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
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
Fasenra (benralizumab) Injection
Class IILack of Assurance of Sterility:
ASTRAZENECA PHARMACEUTICALS · 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…
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 100 eaches per box, 10…
Class IISubpotent Drug
Medline Industries, LP · Sep 29, 2025
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by…
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
Doxycycline Hyclate Tablets
Class IIFailed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Acella Pharmaceuticals, LLC · Sep 29, 2025
Succinylcholine Chloride Injection
Class IIOut-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Dr. Reddy's Laboratories, Inc. · Sep 26, 2025
Aloe Up Sport Performance Sunscreen Lotion SPF 30
Class IIcGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
SV Labs Prescott Corporation · Sep 25, 2025
Entecavir Tablets
Class IIFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Zydus Pharmaceuticals (USA) Inc · Sep 24, 2025
Entecavir Tablets
Class IIFailed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Zydus Pharmaceuticals (USA) Inc · Sep 24, 2025
Fentanyl citrate
Class IICGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Park Avenue Compounding · Sep 23, 2025
Sting Relief Swabs
Class IIProduct Mix-up
ACME UNITED CORPORATION · Sep 23, 2025
Bevacizumab 1.75 mg/0.07 mL
Class IILack of assurance of sterility.
RC Outsourcing, LLC · Sep 22, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Atorvastatin Calcium Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 19, 2025
Phenylephrine HCI
Class IICGMP Deviations
Park Avenue Compounding · Sep 17, 2025
Azelaic Acid Gel
Class IICGMP Deviations: Market complaints received for gritty texture (grainy)
Glenmark Pharmaceuticals Inc., USA · Sep 17, 2025
Levothyroxine Sodium Tablets
Class IISubpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
ACCORD HEALTHCARE, INC. · Sep 16, 2025
Carbamazepine Extended-Release Tablets
Class IIFailed Dissolution Specifications.
Amerisource Health Services LLC · Sep 15, 2025
Bupropion Hydrochloride Extended-Release Tablets USP (XL)
Class IIFailed Tablet/Capsule Specifications
Graviti Pharmaceuticals Private Limited · Sep 15, 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.