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 |
|---|---|---|---|---|
| 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.