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Browse Drug Recalls

6,252 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,252 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 6,252 FDA drug recalls.

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DateProductReasonClassFirm
Sep 21, 2016 Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b)... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vi... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mc... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL I... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compound... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compo... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy,... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compou... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharma... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by We... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by W... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable K... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Well... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy,... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL v... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Com... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy N... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
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
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 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 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 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 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 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 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 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 16, 2016 Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 12, 2016 Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 12, 2016 Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL)... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 12, 2016 Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, ... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 2, 2016 Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... Lack of assurance of sterility Class II United Exchange Corporation

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.