Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
Apr 17, 2013 Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharma... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pha... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Ph... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Ax... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmac... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharma... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a d... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a di... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharm... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, ... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compoun... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmac... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a divisio... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Comprehensive injection #4 - SS varied injectable Injectable Balanced Soluti... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmac... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 15, 2013 The firm is recalling all lots of sterile products compounded by the pharmacy... Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assura... Class II Apothecure, Inc
Apr 15, 2013 HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 15, 2013 Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVisio... Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... Class I NuVision Pharmacy, Inc.
Apr 12, 2013 Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL... Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... Class II OPMX, LLC
Apr 12, 2013 Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl... Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... Class II OPMX, LLC
Apr 10, 2013 Medroxyprogesterone Acetate Injection, all strengths and all presentations in... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 MIC Vitamin Injection, all strengths and all presentations including a) MIC 2... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Methylprednisolone and Dexamethasone Injection, all strengths and all present... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Bacteriostatic Water for Injection, all presentations including 30 mL, Rx onl... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Buprenorphine Injection, all strengths and all presentations including Bupren... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Testosterone Cypionate and Testosterone Propionate Injection, all strengths a... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Bupivacaine Injection, all strengths and all presentations including a) Bupiv... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Dexamethasone Sodium Phosphate Injection, all strengths and all presentations... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Taurine Injection, all strengths and all presentations including a) Taurine 5... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Magnesium Sulfate Injection, all strengths and all presentations including a)... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pil... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil,... Class I Affirm XL, Inc.
Apr 10, 2013 Bupivacaine and Dexamethasone Injection, all strengths and all presentations ... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Ascorbic Acid Injection, all strengths and all presentations including a) 500... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Estradiol Valerate Injection, all strengths and all presentations including a... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Methylprednisolone and Bupivacaine Injection, all strengths and all presentat... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Methylprednisolone Acetate and Marcaine Injection, all strengths and all pres... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Testosterone Cypionate Injection, all strengths and all presentations includi... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations incl... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Metoprolol Injection, all strengths and all presentations including Metoprolo... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Hyaluronidase Injection, all strengths and all presentations including a) Hya... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Lidocaine Injection, all strengths and all presentations including a) Lidocai... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Vitamin D3 Injection, all strengths and all presentations including a) Cholec... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Methylprednisolone Acetate Injection, all strengths and all presentations inc... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Procaine Hydrochloride Injection, all strengths and all presentations, includ... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Sodium Chloride and Dexamethasone Injection, all strengths and all presentati... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 L-Carnitine Injection, all strengths and all presentations including L-Carnit... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs
Apr 10, 2013 Furosemide Injection, all strengths and all presentations including a) Furose... Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... Class II FVS Holdings, Inc. dba. Green Valley Drugs

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.