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Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
Sep 20, 2016 Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL ... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (In... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Vo... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal In... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL T... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Co... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Wa... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Aug 26, 2013 Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Le... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 26, 2013 Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vi... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 26, 2013 Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose via... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy
Aug 26, 2013 Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Co... Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... Class II Leiter's Pharmacy

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.