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.

DateProductReasonClassFirm
Jun 25, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-... Failed Dissolution Specifications Class I Amerisource Health Services LLC
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 24, 2024 Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne ... Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testin... Class III Rising Pharma Holding, Inc.
Jun 24, 2024 SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, ... Sub-potent Drug Class III Neilmed Pharmaceuticals Inc
Jun 21, 2024 Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... Class I A-S Medication Solutions 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, 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, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) P... 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, 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, 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 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, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Package... 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 Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... Subpotent drug: out of specification results Class III Accord Healthcare, 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 5, 2024 STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms Class I 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
Jun 4, 2024 Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Redd... Failed Impurities/Degradation Specifications: Related Substances Class III Dr. Reddy's Laboratories, 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 31, 2024 Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of ho... Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferr... Class III Washington Homeopathic Products, Inc.
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... Failed Dissolution Specifications Class I Glenmark Pharmaceuticals Inc., USA
May 30, 2024 Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for or... Failed Content Uniformity Specifications Class II Lupin Pharmaceuticals Inc.
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... Failed Dissolution Specifications Class I Glenmark Pharmaceuticals Inc., USA
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 28, 2024 Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... Defective Container Class III Organon Llc
May 28, 2024 Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz.... cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel e... Class II Denison Pharmaceuticals, LLC
May 28, 2024 Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose ... Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Class I Sagent Pharmaceuticals
May 28, 2024 Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... Defective Container Class III Organon Llc
May 28, 2024 Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... Defective Container Class III Organon Llc
May 28, 2024 Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the fo... Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum... Class II Consumer Product Partners, LLC
May 28, 2024 Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufact... Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablet... Class II Winder Laboratories, LLC
May 28, 2024 Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Do... Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Class I Sagent Pharmaceuticals
May 24, 2024 suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple S... CGMP Deviations Class II SYNCHRONICITY SPA INC, DBA SUNTE
May 24, 2024 suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broa... Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) Class I SYNCHRONICITY SPA INC, DBA SUNTE
May 23, 2024 Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL ... Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phos... Class II Eugia US LLC
May 23, 2024 Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials... Lack of Assurance of Sterility: Leaking vials Class II Dr. Reddy's Laboratories, Inc.
May 22, 2024 Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mf... Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide... Class III Eugia US LLC
May 22, 2024 OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 3... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... Class II MexHealth LLC
May 20, 2024 Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
May 20, 2024 Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San F... Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo ... Class II Genentech, Inc.
May 20, 2024 Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer 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.