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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.