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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Date	Product	Reason	Class	Firm
Sep 5, 2013	Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern Sta...	Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL ...	Class II	Northern New England Compounding Pharmacy LLC
Sep 4, 2013	Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By:...	Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d...	Class II	Greenstone Llc
Sep 4, 2013	GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-...	Subpotent; phenylephrine HCl	Class III	Hi-Tech Pharmacal Co., Inc.
Sep 4, 2013	Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, ...	Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d...	Class II	Pfizer Us Pharmaceutical Group
Sep 4, 2013	Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By:...	Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d...	Class II	Greenstone Llc
Sep 3, 2013	Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufac...	Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken t...	Class III	Novartis Consumer Health
Aug 30, 2013	Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 ...	Defective Container: Defective bottles may not have tamper evident seals properly seated, and th...	Class III	Watson Laboratories Inc
Aug 30, 2013	SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per...	Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic ...	Class III	Boehringer Ingelheim Roxane Inc
Aug 30, 2013	Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx onl...	Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as...	Class I	Hospira Inc.
Aug 29, 2013	Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen ...	Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped w...	Class II	Procter & Gamble Co
Aug 29, 2013	Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-u...	Presence of Particulate Matter; Glass particulates observed in vials	Class I	Cubist Pharmaceuticals, Inc.
Aug 29, 2013	5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, R...	Presence of Particulate Matter; report of visible particulates in the glass ampule	Class II	Hospira Inc.
Aug 29, 2013	IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05)...	Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an inco...	Class II	Dr. Reddy's Laboratories, Inc.
Aug 26, 2013	EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Cr...	Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection...	Class II	Pharmacy Creations
Aug 26, 2013	Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Le...	Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af...	Class II	Leiter's Pharmacy
Aug 26, 2013	Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations...	Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection...	Class II	Pharmacy Creations
Aug 26, 2013	Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vi...	Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af...	Class II	Leiter's Pharmacy
Aug 26, 2013	Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose via...	Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af...	Class II	Leiter's Pharmacy
Aug 26, 2013	Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Co...	Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af...	Class II	Leiter's Pharmacy
Aug 23, 2013	NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-80...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solu...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	JCB Labs LLC
Aug 23, 2013	Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 m...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind...	Class II	Wellness Pharmacy, Inc.
Aug 23, 2013	L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vial...	Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcoba...	Class II	South Coast Specialty Compounding, Inc.
Aug 23, 2013	Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMAC...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind...	Class II	Wellness Pharmacy, Inc.
Aug 23, 2013	Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS ...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind...	Class II	Wellness Pharmacy, Inc.
Aug 23, 2013	Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 3...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	JCB Labs LLC
Aug 23, 2013	Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELL...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind...	Class II	Wellness Pharmacy, Inc.
Aug 23, 2013	Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627	The product lots are being recalled due to laboratory results indicating microbial contamination....	Class II	Wellness Pharmacy, Inc.
Aug 23, 2013	Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	Medaus, Inc.
Aug 23, 2013	Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	JCB Labs LLC
Aug 23, 2013	Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL...	Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace...	Class II	South Coast Specialty Compounding, Inc.
Aug 23, 2013	CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL ...	CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was...	Class II	Central Shared Services dba Parallon
Aug 23, 2013	Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile...	Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace...	Class II	South Coast Specialty Compounding, Inc.
Aug 23, 2013	Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Inje...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	JCB Labs LLC
Aug 23, 2013	Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative C...	Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or po...	Class II	Creative Compounds
Aug 23, 2013	Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, In...	Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone...	Class II	Walgreens Co
Aug 23, 2013	Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-2...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind...	Class II	Wellness Pharmacy, Inc.
Aug 23, 2013	Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Fre...	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr...	Class II	JCB Labs LLC
Aug 21, 2013	buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table...	Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2...	Class III	Actavis South Atlantic LLC
Aug 17, 2013	Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne...	Failed dissolution specifications; 18 month CRT	Class II	Amneal Pharmaceuticals of New York, LLC.
Aug 16, 2013	Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic,...	Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at ...	Class II	Hospira Inc.
Aug 14, 2013	Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet She...	Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil	Class I	Fabscout Entertainment, Inc
Aug 14, 2013	Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For ...	Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under...	Class II	Novocol Pharmaceutical of Canada
Aug 14, 2013	PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsu...	Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil	Class I	Fabscout Entertainment, 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.