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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 Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded b... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells P... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Well... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wel... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wel... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded b... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounde... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injecta... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compo... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
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
Sep 19, 2016 Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Net... Superpotent and Subpotent drugs Class II Wells Pharmacy Network, LLC
Sep 19, 2016 Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Ne... Superpotent and Subpotent drugs Class II Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class III Wells Pharmacy Network, LLC
Sep 19, 2016 Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Ne... Superpotent and Subpotent drugs Class II Wells Pharmacy Network, LLC
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 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 15, 2016 PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx o... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expi... Class III Pfizer Inc.
Sep 15, 2016 Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto... Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod... Class III Mckesson Packaging Services
Sep 13, 2016 mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... Failed Impurities/Degradation Specifications: potential failure to meet the specification for Imp... Class III Teva Pharmaceuticals USA
Sep 13, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-D... Failed Dissolution Specifications Class III Sun Pharmaceutical Industries, Inc.
Sep 13, 2016 Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals ... Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Mod... Class II Taro Pharmaceuticals, Inc.
Sep 13, 2016 Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals ... Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Mod... Class II Taro Pharmaceuticals, Inc.
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 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 Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottle... Superpotent Drug and Subpotent Drug; potency failures obtained Class II MOORE'S COMPOUNDING PHARMACY
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 9, 2016 Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For... Failed Impurities/Degradations Specifications; Out of specification results for two known degrada... Class III Pfizer Inc.

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.