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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
May 2, 2013 Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Sin... Presence of Particulate Matter: visible particles were identified floating in the primary container. Class II Hospira Inc.
May 2, 2013 Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by Th... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compo... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Com... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Pet... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding S... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compoundin... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The C... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectabl... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, co... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. P... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding S... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded b... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Pap... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 1, 2013 CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed ... cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled in... Class II Medicis Pharmaceutical Corp
May 1, 2013 Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister pac... Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ... Class I Beamonstar Products
May 1, 2013 SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister pac... Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ... Class I Beamonstar Products
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... Subpotent; 24 month stability test station Class III Hi-Tech Pharmacal Co., Inc.
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL ba... Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Class II Hospira Inc.
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box,... Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... Class I American Lifestyle.Com
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold l... Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... Class I American Lifestyle.Com
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 26, 2013 Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0... Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin p... Class III Teva Pharmaceuticals USA, Inc.
Apr 24, 2013 Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactu... Marketed without an Approved NDA/ANDA. Class II Insight Instruments, Inc.
Apr 22, 2013 Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 9... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-0... Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was f... Class II Mylan Pharmaceuticals Inc.
Apr 22, 2013 Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, Inc.
Apr 22, 2013 HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Nora Apothecary and Alternative Therapies, 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.