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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 12,321–12,340 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

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Drug Recall Terminated Historical recordClass II

Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

by Safecor Health, LLC

Reason
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Recall initiated
July 16, 2015
Reported by FDA
April 6, 2016
Distribution
NY

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Drug Recall Terminated Historical recordClass II

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52

by Dr. Reddy's Laboratories, Inc.

Reason
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Recall initiated
March 3, 2016
Reported by FDA
April 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

by Praxair Inc.

Reason
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Recall initiated
September 16, 2015
Reported by FDA
April 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.

by Praxair Inc.

Reason
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Recall initiated
September 16, 2015
Reported by FDA
April 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.

by AstraZeneca Pharmaceuticals LP

Reason
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Recall initiated
February 5, 2016
Reported by FDA
March 30, 2016
Distribution
US: Nationwide Including Puerto Rico

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Drug Recall Terminated Historical recordClass II

Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82

by Sagent Pharmaceuticals Inc

Reason
Cross contamination with other products: metronidazole
Recall initiated
March 1, 2016
Reported by FDA
March 30, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01

by AGA Gas Inc

Reason
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Recall initiated
November 29, 2015
Reported by FDA
March 30, 2016
Distribution
Product was delivered to Ohio

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Drug Recall Terminated Historical recordClass III

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

by PharMEDium Services, LLC

Reason
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Recall initiated
December 31, 2015
Reported by FDA
March 23, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

by PharMEDium Services, LLC

Reason
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Recall initiated
December 31, 2015
Reported by FDA
March 23, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.

by Medical Park Homecare, Inc

Reason
CGMP Deviations: Cylinders filled using out of date gauges.
Recall initiated
February 5, 2016
Reported by FDA
March 23, 2016
Distribution
U.S. Including: Oklahoma

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Drug Recall Terminated Historical recordClass III

Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL

by Virtus Pharmaceuticals, Llc

Reason
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Recall initiated
January 15, 2016
Reported by FDA
March 23, 2016
Distribution
MI

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Drug Recall Terminated Historical recordClass II

Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Recall initiated
February 5, 2016
Reported by FDA
March 23, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL

by Teva Pharmaceuticals USA

Reason
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Recall initiated
November 19, 2015
Reported by FDA
March 23, 2016
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass I

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748

by Tf Supplements

Reason
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Recall initiated
September 25, 2015
Reported by FDA
March 16, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

by Tf Supplements

Reason
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Recall initiated
September 25, 2015
Reported by FDA
March 16, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77

by Golden State Medical Supply Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
January 27, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77

by Golden State Medical Supply Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
January 27, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77

by Golden State Medical Supply Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
January 27, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77

by Golden State Medical Supply Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
January 27, 2016
Reported by FDA
March 16, 2016
Distribution
Nationwide

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.