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Browse Drug Recalls

62 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 62 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 62 FDA drug recalls.

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DateProductReasonClassFirm
Dec 6, 2021 Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropp... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dro... Lack of Assurance of Sterility. Class II Edge Pharma, LLC
Apr 12, 2021 Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, ... Defective container; syringe content migrating past the seal of the plunger may cause a lack of a... Class II Edge Pharma, LLC
Feb 17, 2021 Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Pres... Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rath... Class III Edge Pharma, LLC
Dec 22, 2020 Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Edge Pharma, LLC
Jul 2, 2020 Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446... Labeling: Label Error on Declared Strength Class II Edge Pharma, LLC
Mar 19, 2020 Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 19, 2020 Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, 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.