Browse Drug Recalls

2,138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,138 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 2,138 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Dec 27, 2013	Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz.,...	Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia...	Class II	Mangiacotti
Dec 27, 2013	Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spr...	Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia...	Class II	Mangiacotti
Dec 27, 2013	Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 m...	Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia...	Class II	Mangiacotti
Dec 27, 2013	Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL ...	Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia...	Class II	Mangiacotti
Dec 12, 2013	Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ...	Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo...	Class I	Zions RX Formulations Services LLC dba RX Formu...
Nov 26, 2013	Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli...	Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with ...	Class II	Humco Holding Group, Inc
Nov 22, 2013	Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-...	Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found...	Class II	Faria Limited LLC dba Sheffield Pharmaceuticals
Nov 22, 2013	FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBU...	Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found...	Class II	Faria Limited LLC dba Sheffield Pharmaceuticals
Nov 22, 2013	Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBU...	Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found...	Class II	Faria Limited LLC dba Sheffield Pharmaceuticals
Nov 16, 2013	Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy...	Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Na...	Class II	Tower Pharmacy and Compounding
Oct 22, 2013	Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured ...	Cross Contamination with Other Products: findings of carryover of trace amounts of a previously m...	Class II	Sandoz Incorporated
Oct 9, 2013	Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac...	Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended ...	Class II	Sandoz, Inc
Sep 24, 2013	Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vani...	Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen ...	Class II	W.S. Badger Company Inc.
Sep 24, 2013	Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Cal...	Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen ...	Class II	W.S. Badger Company Inc.
Sep 6, 2013	Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL ...	Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro...	Class II	Triangle Compounding
Sep 6, 2013	Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, ...	Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro...	Class II	Triangle Compounding
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 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	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	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 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 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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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 9, 2013	CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% ...	Non Sterility: Microbial contamination	Class I	Specialty Compounding, LLC
Aug 8, 2013	Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.
Aug 8, 2013	Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia...	Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle...	Class II	Novartis Pharmaceuticals Corp.

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.