Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufa... | 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 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by B... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, 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 | Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc.... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes,... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, 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 | Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottl... | 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 | 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 | Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, F... | 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 | 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 | Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured ... | 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 | Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx on... | 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 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Di... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| 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 | 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 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 | Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 ... | 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 | 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 | 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 | 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 | Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a... | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL 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 | 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 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. |
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.