Skip to main content
Get Alerts

FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

Filters
Recall details
Location
Date range
Clear filters

Showing 13,721–13,740 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
June 1, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.

by MYLAN PHARMACEUTICALS INC

Reason
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Recall initiated
June 30, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

by Hospira Inc.

Reason
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Recall initiated
April 23, 2015
Reported by FDA
July 15, 2015
Distribution
U.S. Nationwide including Guam.

View recall →

Drug Recall Terminated Historical recordClass II

Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1

by Apotex Inc.

Reason
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Recall initiated
May 29, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide, Hawaii and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9

by Apotex Inc.

Reason
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Recall initiated
May 29, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide, Hawaii and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9

by Apotex Inc.

Reason
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Recall initiated
May 29, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide, Hawaii and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9

by Apotex Inc.

Reason
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Recall initiated
May 29, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide, Hawaii and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall initiated
March 24, 2015
Reported by FDA
July 15, 2015
Distribution
US, Puerto Rico, and Bermuda

View recall →

Drug Recall Terminated Historical recordClass I

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall initiated
March 24, 2015
Reported by FDA
July 15, 2015
Distribution
US, Puerto Rico, and Bermuda

View recall →

Drug Recall Terminated Historical recordClass I

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall initiated
March 24, 2015
Reported by FDA
July 15, 2015
Distribution
US, Puerto Rico, and Bermuda

View recall →

Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall initiated
March 24, 2015
Reported by FDA
July 15, 2015
Distribution
US, Puerto Rico, and Bermuda

View recall →

Drug Recall Terminated Historical recordClass I

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

by Bethel Nutritional Consulting, Inc

Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Recall initiated
December 19, 2014
Reported by FDA
July 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Recall initiated
April 28, 2015
Reported by FDA
July 15, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.

by Takeda Pharmaceuticals North America, Inc.

Reason
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Recall initiated
May 21, 2015
Reported by FDA
July 8, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.