Browse Drug Recalls
17,539 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,539 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 17,539 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2025 | Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Pack... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Aug 20, 2025 | Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo ... | Discoloration | Class II | Baxter Healthcare Corporation |
| Aug 19, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph... | Class II | Lannett Company Inc. |
| Aug 19, 2025 | READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile,... | Subpotent drug | Class III | Medline Industries, LP |
| Aug 18, 2025 | Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medica... | Presence of Particulate Matter | Class I | B BRAUN MEDICAL INC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, ... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, ... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only,... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medi... | Presence of Particulate Matter. | Class I | B BRAUN MEDICAL INC |
| Aug 13, 2025 | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in... | Temperature Abuse | Class II | Sandoz Inc |
| Aug 12, 2025 | Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical ... | Discoloration | Class II | VIONA PHARMACEUTICALS INC |
| Aug 11, 2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... | Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained... | Class II | Lannett Company Inc. |
| Aug 8, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, R... | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Aug 8, 2025 | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by ... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured ... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 5, 2025 | Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Front... | Presence of foreign substance: identified as aluminum. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Aug 5, 2025 | Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... | Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... | Class II | Cardinal Health Inc. |
| Aug 5, 2025 | Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL... | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W... | Class III | Haleon US Holdings LLC |
| Aug 4, 2025 | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... | Lack of Assurance of Sterility. | Class II | PFIZER INC |
| Aug 4, 2025 | Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... | Lack of Assurance of Sterility. | Class II | PFIZER INC |
| Aug 4, 2025 | Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Class II | B BRAUN MEDICAL INC |
| Aug 4, 2025 | 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Class II | B BRAUN MEDICAL INC |
| Jul 30, 2025 | Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 28... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Semaglutide with B12 for Injection, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | Sterile Saline Reconstitution Solution for Injection, all strengths and prese... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL M... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and present... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intrave... | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the imp... | Class II | Exela Pharma Sciences LLC |
| Jul 30, 2025 | L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 m... | Microbial Contamination of Sterile Products: elevated endotoxin levels | Class I | GenoGenix LLC |
| Jul 30, 2025 | Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
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.