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 |
|---|---|---|---|---|
| Oct 10, 2024 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Oct 9, 2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratorie... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 8, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) p... | CGMP violations. | Class II | Neogen Corporation |
| Oct 8, 2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, | Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class II | C & A Naturistics |
| Oct 8, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL... | CGMP violations. | Class II | Neogen Corporation |
| Oct 1, 2024 | Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... | Failed Impurities/Degradation Specifications. | Class II | ACCORD HEALTHCARE, INC. |
| Sep 30, 2024 | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only... | Defective Container: Firm received complaints of broken tube at the seal. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Sep 30, 2024 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, ... | Presence of Particulate Matter: Presence of glass particulates. | Class I | Staska Pharmaceuticals, Inc. |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... | CGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin... | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... | Class III | Denison Pharmaceuticals, LLC |
| Sep 25, 2024 | Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single D... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin,... | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... | Class III | Denison Pharmaceuticals, LLC |
| Sep 25, 2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose B... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose ... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 24, 2024 | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Ma... | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in... | Class II | Nivagen Pharmaceuticals Inc |
| Sep 24, 2024 | Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665... | Defective Delivery System: The dip tube is clogged causing the spray not to work. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 24, 2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences ... | Crystallization | Class II | VIONA PHARMACEUTICALS INC |
| Sep 23, 2024 | Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan in... | CGMP deviations | Class II | Advanced Accelerator Applications USA, Inc. |
| Sep 19, 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: Presence of glass particle. | Class I | Gilead Sciences, Inc. |
| Sep 18, 2024 | EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz... | CGMP deviations | Class II | EnviroServe Chemicals Inc. |
| Sep 18, 2024 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sd... | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone ... | Class I | 123Herbals |
| Sep 17, 2024 | Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distribu... | Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with C... | Class I | Bionpharma Inc. |
| Sep 16, 2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Sep 16, 2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Sep 11, 2024 | Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Singl... | cGMP Deviations: Temperature excursion | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 11, 2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... | Temperature abuse: Products exposed to improper temperature above drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| 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 24, 2024 | AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed b... | Discoloration | Class III | Rubicon Research Private Limited |
| 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 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 | 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 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded... | 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 | 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 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 20, 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... | LABELING: LABEL MIX-UP. | Class III | Elevate Oral Care |
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.