Browse Drug Recalls
18,008 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,008 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 18,008 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 13, 2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 m... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper b... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-... | Failed Stability Specifications | Class III | Aadi Bioscience |
| Oct 11, 2022 | NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN ... | Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg | Class III | LNK International, Inc. |
| Oct 11, 2022 | 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... | Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 7, 2022 | MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx o... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compo... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder,... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vita... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, ... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTI... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital C... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vita... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit do... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Ca... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... | Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. | Class I | Viatris Inc |
| Oct 7, 2022 | PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL via... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care C... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vi... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 m... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital ... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL sy... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital ... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL ... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTI... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Ca... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care ... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Ca... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials,... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
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.