Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2024 | First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients:... | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes ... | Class II | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
| Sep 5, 2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose... | Lack of Assurance of Sterility | Class II | Empower Pharmacy |
| Sep 3, 2024 | Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc ... | Microbial Contamination of Non-Sterile Product | Class II | Vivier Pharma, Inc. |
| Sep 3, 2024 | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets p... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Aug 30, 2024 | Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmac... | Subpotent Drug | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 28, 2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML... | Microbial contamination of non-sterile Products - | Class II | PREQUEL SKIN |
| Aug 22, 2024 | Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, C... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: P... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Com... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass ... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vi... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: P... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Aug 22, 2024 | SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| 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 | Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Te... | Superpotent Drug | Class II | Teva Pharmaceuticals USA, Inc |
| 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 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, 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, 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 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 | 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 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 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, 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 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, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0... | CGMP deviations | Class II | Little Moon Essentials 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.