Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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Date	Product	Reason	Class	Firm
Jun 25, 2014	Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 10...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial an...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use,...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 m...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Ph...	Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold co...	Class I	Pharmacy Creations
Jun 25, 2014	Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or D...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 25, 2014	Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufacture...	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because t...	Class II	Medical Supply Liquidators Llc
Jun 24, 2014	Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 7...	Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this...	Class II	Doctor's Best, Inc.
Jun 20, 2014	Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint F...	Failed Impurity/Degradation Specification; 12-month stability time point	Class III	Novel Laboratories, Inc.
Jun 20, 2014	Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharma...	Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.	Class III	Mylan Pharmaceuticals Inc.
Jun 19, 2014	Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bott...	Failed Dissolution Specifications: Drug failed stage III dissolution testing.	Class II	Forest Pharmaceuticals Inc
Jun 19, 2014	Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ...	Failed Dissolution Specification; at the 12 month time interval.	Class III	Mckesson Packaging Services
Jun 19, 2014	Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottl...	Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications f...	Class III	Pfizer Inc.
Jun 19, 2014	Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx on...	Failed Impurities/Degradation Specifications: High out-of-specification results for a related com...	Class III	Mylan Pharmaceuticals Inc.
Jun 17, 2014	Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (15...	Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ...	Class I	Hospira Inc.
Jun 17, 2014	Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0....	Failed Impurities/Degradation Specifications: out of specification impurity test results.	Class III	Teva Pharmaceuticals USA
Jun 17, 2014	Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyc...	Failed Impurities/Degradation Specifications: out of specification impurity test results.	Class III	Teva Pharmaceuticals USA
Jun 17, 2014	Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 ...	Failed Impurities/Degradation Specifications: out of specification impurity test results.	Class III	Teva Pharmaceuticals USA
Jun 17, 2014	Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15...	Failed Impurities/Degradation Specifications: out of specification impurity test results.	Class III	Teva Pharmaceuticals USA
Jun 16, 2014	Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500...	Presence of Particulate Matter: Complaints received of discolored solution identified as subvisib...	Class II	Baxter Healthcare Corp.
Jun 12, 2014	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged...	Failed Dissolution Specifications: Stability results found the product did not meet the drug diss...	Class II	Caraco Pharmaceutical Laboratories, Ltd.
Jun 12, 2014	Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bo...	Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme...	Class II	Thorne Research Inc
Jun 12, 2014	Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles...	Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme...	Class II	Thorne Research Inc
Jun 6, 2014	Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/25...	Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container...	Class II	Hospira Inc.
Jun 6, 2014	DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorop...	Stability Data Does Not Support Expiry	Class III	Estee Lauder Inc
Jun 5, 2014	Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, ...	Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets...	Class II	Teva Pharmaceuticals USA
Jun 5, 2014	APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co...	Labeling: Incorrect or Missing Package Insert	Class III	Valeant Pharmaceuticals North America LLC
Jun 5, 2014	APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co...	Labeling: Incorrect or Missing Package Insert	Class III	Valeant Pharmaceuticals North America LLC
Jun 5, 2014	APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count...	Labeling: Incorrect or Missing Package Insert	Class III	Valeant Pharmaceuticals North America LLC
Jun 2, 2014	Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808	Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked i...	Class II	Unit Dose Solutions Inc
Jun 2, 2014	Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only...	Presence of Particulate Matter: Product failed the appearance for the presence of visible particl...	Class I	Alexion Pharmaceuticals, Inc.
May 30, 2014	Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only...	Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.	Class II	Brookfield Prescription Center Inc. dba MD Cust...
May 30, 2014	HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 1903...	Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.	Class II	Brookfield Prescription Center Inc. dba MD Cust...
May 30, 2014	HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx on...	Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.	Class II	Brookfield Prescription Center Inc. dba MD Cust...
May 30, 2014	Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Cus...	Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.	Class II	Brookfield Prescription Center Inc. dba MD Cust...
May 30, 2014	HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units...	Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.	Class II	Brookfield Prescription Center Inc. dba MD Cust...
May 30, 2014	HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL ...	Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.	Class II	Brookfield Prescription Center Inc. dba MD Cust...
May 29, 2014	Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for T...	Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one...	Class II	Teva Pharmaceuticals USA
May 28, 2014	Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule...	Failed Stability Specification; out of specification result for particle size distribution during...	Class III	Novartis Pharmaceuticals Corp.
May 28, 2014	del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph...	Non Sterility; microbial contamination identified as Aspergillus species	Class I	Central Admixture Pharmacy Services, Inc.
May 28, 2014	adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha...	Non Sterility; microbial contamination identified as Aspergillus species	Class I	Central Admixture Pharmacy Services, Inc.
May 28, 2014	PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,...	Non Sterility; microbial contamination identified as Aspergillus species	Class I	Central Admixture Pharmacy Services, Inc.
May 28, 2014	LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic...	Non Sterility; microbial contamination identified as Aspergillus species	Class I	Central Admixture Pharmacy Services, Inc.
May 23, 2014	Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-cou...	Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2014	Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex P...	Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofl...	Class II	Aidarex Pharmaceuticals LLC

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.