Browse Drug Recalls

14,136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,136 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 14,136 FDA drug recalls — Class II.

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DateProductReasonClassFirm
Aug 21, 2024 Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month lon... Class II Lupin Pharmaceuticals Inc.
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 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 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 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
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 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 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 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 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 9, 2024 Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules p... Failed Dissolution Specifications Class II SUN PHARMACEUTICAL INDUSTRIES 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 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
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 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 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 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 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 24, 2024 buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg,... Failed Dissolution Specifications; the product is dissolving faster than the specified limits. Class II Amerisource Health Services LLC
Jun 21, 2024 Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in ... Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing ... Class II Zydus Pharmaceuticals (USA) Inc
Jun 20, 2024 Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UP... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL ... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packag... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as ... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) P... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Package... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) pa... CGMP deviations Class II Little Moon Essentials LLC
Jun 18, 2024 DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% D... This product is being recalled due to the tube weld failure presents itself as a slow leak and ca... Class II Fresenius Medical Care Holdings, Inc.
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained during routine stability ... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jun 17, 2024 Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count... Failed dissolution specifications: this product is being recalled due to this batch not meeting d... Class II Trigen Laboratories
Jun 17, 2024 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... Class II Baxter Healthcare Corporation
Jun 12, 2024 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing... Class II PACIRA PHARMACEUTICALS INC
Jun 10, 2024 Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), p... Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination Class II Brands International Corporation
Jun 7, 2024 Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured... Presence of foreign substance. Class II Dr. Reddy's Laboratories, Inc.
Jun 5, 2024 STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473... Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism Class II Homeocare Laboratories, Inc.
Jun 4, 2024 Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-co... Subpotent Drug Class II Teva Pharmaceuticals USA, Inc
May 31, 2024 Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ... Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbita... Class II RemedyRepack Inc.
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA

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.