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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 12,361–12,380 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

by Hartley Medical Center Pharmacy, Incorporated

Reason
Lack of Assurance of Sterility
Recall initiated
February 4, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.

by Sun Pharma Global Fze

Reason
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Recall initiated
February 11, 2016
Reported by FDA
March 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654

by J. Strickland and Co

Reason
Subpotent Drug: failed at the 3 and 6 month stability time points.
Recall initiated
February 11, 2016
Reported by FDA
March 9, 2016
Distribution
Nationwide, Jamaica and Bahamas

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023

by TexasStar Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
December 29, 2015
Reported by FDA
March 9, 2016
Distribution
TX

View recall →

Drug Recall Terminated Historical recordClass II

Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89

by Teva North America

Reason
Failed Dissolution Specifications: low test results at the 18 month time-point
Recall initiated
December 21, 2015
Reported by FDA
March 9, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03

by Baxter Healthcare Corp.

Reason
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Recall initiated
February 5, 2016
Reported by FDA
March 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.

by Genzyme Corporation

Reason
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Recall initiated
February 16, 2016
Reported by FDA
March 9, 2016
Distribution
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.

View recall →

Drug Recall Terminated Historical recordClass II

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.

by Genzyme Corporation

Reason
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Recall initiated
February 16, 2016
Reported by FDA
March 9, 2016
Distribution
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.

View recall →

Drug Recall Terminated Historical recordClass III

Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109

by Isomeric Pharmacy Solution, LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.
Recall initiated
February 2, 2016
Reported by FDA
March 2, 2016
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

by Hospira Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Recall initiated
February 2, 2016
Reported by FDA
March 2, 2016
Distribution
Nationwide and Hong Kong

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.