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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.

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Showing 15,041–15,060 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing.

by HLI dba Humphreyline Inc

Reason
Microbial Contamination of Non-Sterile Product
Recall initiated
August 6, 2014
Reported by FDA
August 13, 2014
Distribution
Kentucky, Maryland, and Virginia.

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Drug Recall Terminated Historical recordClass II

Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5

by SST Corporation

Reason
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Recall initiated
July 17, 2014
Reported by FDA
August 13, 2014
Distribution
CA

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Drug Recall Terminated Historical recordClass III

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.

by Novartis Pharmaceuticals Corp.

Reason
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Recall initiated
July 30, 2014
Reported by FDA
August 13, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10

by Mckesson Packaging Services

Reason
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Recall initiated
July 30, 2014
Reported by FDA
August 13, 2014
Distribution
CO & OH

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Drug Recall Terminated Historical recordClass II

Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11

by Janssen Pharmaceuticals, Inc.

Reason
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Recall initiated
September 11, 2013
Reported by FDA
August 13, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

by Wockhardt Usa Inc.

Reason
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Recall initiated
July 14, 2014
Reported by FDA
August 13, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.

by Alexion Pharmaceuticals, Inc.

Reason
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Recall initiated
June 2, 2014
Reported by FDA
August 13, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Recall initiated
June 26, 2014
Reported by FDA
August 13, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Recall initiated
June 26, 2014
Reported by FDA
August 13, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

by Sandoz Incorporated

Reason
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Recall initiated
July 25, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Recall initiated
July 12, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90

by Jubilant Cadista Pharmaceuticals Inc.

Reason
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Recall initiated
July 11, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Recall initiated
April 1, 2014
Reported by FDA
August 6, 2014
Distribution
Nationwide

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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.