Browse Drug Recalls
1,122 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,122 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 1,122 FDA drug recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2023 | Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx On... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 m... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only,... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Ste... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufac... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutan... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufac... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Int... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 coun... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, D... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Dis... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distr... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Ak... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, Fo... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Ak... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distribute... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured b... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tub... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, pack... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 24, 2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... | Product mixup: one foreign tablet found in product. | Class III | The Harvard Drug Group |
| Apr 20, 2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... | Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... | Class III | Bryant Ranch Prepack, Inc. |
| Apr 20, 2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric... | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Class I | Novis PR, LLC dba Kramer Novis |
| Apr 19, 2023 | Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Sol... | Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the label... | Class II | Seatex LLC |
| Apr 19, 2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Ster... | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Class II | Sun Pharmaceutical Industries Ltd. |
| Apr 13, 2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / ... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder ... | Lack of assurance of sterility. | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Apr 11, 2023 | Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... | Lack of Assurance of Sterility: Malformed crimped collar seal | Class II | Sanofi-Aventis U.S. LLC |
| Apr 10, 2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... | Subpotent Drug: Out of specification results for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Apr 7, 2023 | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For... | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inven... | Class II | Methapharm Inc |
| Apr 6, 2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 m... | CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. | Class II | Pharma Nobis LLC |
| Apr 6, 2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limite... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Apr 6, 2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Mar 31, 2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, 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.