Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2023 | Valproic Acid Oral Solution, USP, 250mg/5mL, 473 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 | Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufacture... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| 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 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. |
| Mar 31, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 31, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count ... | CGMP deviation: product outside labeled storage temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-steril... | CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of met... | Class II | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, 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.