Browse Drug Recalls

201 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 201 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 201 FDA drug recalls.

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DateProductReasonClassFirm
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx on... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Oct 7, 2025 Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... Class II Teva Pharmaceuticals USA, Inc
Apr 25, 2025 Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Sin... Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 25, 2025 Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) an... Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 15, 2025 HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette,... Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was ... Class III OurPharma LLC
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose ... Super-Potent Drug: Out of specification potency results were obtained. Class II Mylan Institutional, Inc.
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose... Super-Potent Drug: Out of specification potency results were obtained. Class II Mylan Institutional, Inc.
Feb 20, 2025 Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Ca... Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and... Class I One Source Nutrition, Inc,
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Apr 8, 2024 Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 8, 2024 Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Jan 22, 2024 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... Class II IntegraDose Compounding Services LLC
Oct 20, 2023 Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only,... Sub-potent Drug: Lower potency than labeled. Class III Zyla Life Sciences US Inc.
May 9, 2023 Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dext... Subpotent: Low anti-factor IIa Potency. Class II B. Braun Medical Inc
Apr 10, 2023 Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... Subpotent Drug: Out of specification results for low potency was obtained. Class III SCA Pharmaceuticals
Mar 1, 2023 Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dext... Subpotent Drug: low Anti-Factor IIa potency. Class II B. Braun Medical Inc
Dec 5, 2022 Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315... Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. Class II RemedyRepack Inc.
May 13, 2022 Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Hom... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Hom... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, O... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington ... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Ho... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washin... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liqu... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washi... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washi... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pell... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... cGMP deviations Class II Washington Homeopathic Products, Inc.
May 13, 2022 Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liqu... cGMP deviations Class II Washington Homeopathic Products, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.