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 15, 2024 | Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 sili... | Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes pac... | Class III | Biocompatibles UK, Ltd. |
| Aug 15, 2024 | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx o... | Lack of Assurance of Sterility | Class II | Fagron Compounding Services |
| Aug 12, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (ND... | Defective Container: patients are unable to get the solution out of the bottle as the spike of th... | Class II | FDC Limited |
| Aug 9, 2024 | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 80... | Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-mo... | Class II | Direct Rx |
| Aug 8, 2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... | Failed Impurities/Degradation Specifications - at 18-month Stability testing | Class II | Preferred Pharmaceuticals, Inc. |
| Aug 8, 2024 | Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Te... | Superpotent Drug | Class II | Teva Pharmaceuticals USA, Inc |
| Aug 7, 2024 | Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Aug 6, 2024 | IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laborat... | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 6, 2024 | IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laborat... | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 6, 2024 | IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laborat... | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 5, 2024 | Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a)... | CGMP Deviations: sterile water not used for production | Class II | Zeco LLC |
| Aug 5, 2024 | HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) ... | CGMP Deviations: sterile water not used for production | Class II | Zeco LLC |
| Aug 2, 2024 | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multipl... | Lack of Assurance of Sterility | Class II | EMPOWER CLINIC SERVICES LLC |
| Aug 1, 2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: ... | Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg with... | Class III | Amneal Pharmaceuticals, LLC |
| Aug 1, 2024 | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Class I | Baxter Healthcare Corporation |
| Jul 31, 2024 | Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count b... | Failed Dissolution Specifications: below specification results | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 31, 2024 | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by:... | Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabap... | Class II | Granules Pharmaceuticals Inc. |
| Jul 26, 2024 | Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose ... | Presence of Particulate Matter: Complaint received of a glass particle in the vial. | Class II | Eugia US LLC |
| Jul 24, 2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... | Presence of Particulate Matter | Class I | B. Braun Medical Inc |
| Jul 23, 2024 | Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 1... | Defective container: unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Jul 22, 2024 | Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 18, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... | Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Dicl... | Class I | MAIN PRODUCTS INC |
| Jul 18, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective container; yellow colored spike from cap lodged in the nozzle | Class II | FDC Limited |
| Jul 18, 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... | Label mix-up: Carton incorrectly labeled. | Class III | Granules Consumer Health Inc. |
| Jul 12, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared D... | Class I | SoloVital |
| Jul 12, 2024 | Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199 | Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared ... | Class I | Supercore Products Group Inc. |
| Jul 12, 2024 | Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and ... | Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared ... | Class I | Supercore Products Group Inc. |
| Jul 11, 2024 | Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 ... | Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the ... | Class I | Aurobindo Pharma USA Inc |
| Jul 10, 2024 | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... | Class I | Endo Pharmaceuticals, Inc. |
| Jul 9, 2024 | Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules p... | Failed Dissolution Specifications | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 8, 2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... | Class I | Hikma Pharmaceuticals USA Inc. |
| Jul 3, 2024 | Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:20... | Subpotent Drug: reduced efficacy for epinephrine | Class II | TAILSTORM HEALTH INC |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorba... | Defective container: potential for non-sealed pouches which can lead to product leakage. | Class III | Novel Laboratories, Inc. d.b.a Lupin Somerset |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotox... | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltere... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jun 28, 2024 | Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 684... | Failed Dissolution Specifications: results below specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 28, 2024 | Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, ... | Failed Impurities/Degradation Specifications: Product is being recalled due to API related substa... | Class II | Teva Pharmaceuticals USA, Inc |
| Jun 27, 2024 | Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only,... | Presence of particulate matter: glass | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jun 26, 2024 | Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... | CGMP Deviations and Presence of Particulate Matter: Glass | Class II | Medisca Inc. |
| Jun 26, 2024 | Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... | CGMP Deviations: Out of specification for dissolution | Class II | RemedyRepack Inc. |
| Jun 26, 2024 | Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 6... | Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared a... | Class II | Guru Inc. |
| Jun 26, 2024 | Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML... | CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. | Class II | Equibal Inc |
| Jun 26, 2024 | Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... | Class III | Dr. Reddy's Laboratories, Inc. |
| 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%), 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 | 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%), 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 |
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.