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Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Comp... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Well... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Comp... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, C... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 m... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compoun... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophil... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Well... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 m... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded b... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compound... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compo... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable K... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL via... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, O... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectab... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Com... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial,... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 3... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compou... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounde... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharma... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compo... Lack of Assurance of Sterility Class II Wells Pharmacy Network 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.