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 13,601–13,620 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Recall initiated
July 29, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86

by Sun Pharma Global Fze

Reason
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Recall initiated
July 17, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall initiated
July 17, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Recall initiated
July 17, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
March 23, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
March 23, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
March 23, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
March 18, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.

by GC Natural Nutrition, Inc.

Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Recall initiated
June 12, 2015
Reported by FDA
August 26, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
April 23, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
March 18, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

by Fresenius Kabi USA, LLC

Reason
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Recall initiated
July 28, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Recall initiated
July 2, 2015
Reported by FDA
August 19, 2015
Distribution
TX and TN

View recall →

Drug Recall Terminated Historical recordClass II

Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
August 3, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recall initiated
July 15, 2015
Reported by FDA
August 19, 2015
Distribution
Nationwide, Puerto Rico & Taiwan

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.