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 14,581–14,600 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Ertapenem various strength in normal saline bags

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Imipenem/ cilastatin various strength in normal saline bags

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Ceftazidime various strength in normal saline bags

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Cefoxitin various strength in normal saline bags

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Cefepime various strengths in normal saline

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Aztreonam 1 gram in normal saline

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Amikacin various strength in normal saline bags

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Liposomal Amphotericin B 130 mg in dextrose bags

by Walgreens Infusion Services

Reason
Lack of sterility assurance.
Recall initiated
December 26, 2014
Reported by FDA
January 28, 2015
Distribution
Texas, Florida, Virginia, Georgia, Louisiana, Mississippi

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059

by SCA Pharmaceuticals

Reason
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Recall initiated
January 2, 2015
Reported by FDA
January 21, 2015
Distribution
Louisiana

View recall →

Drug Recall Terminated Historical recordClass II

Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.

by Actavis Elizabeth LLC

Reason
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Recall initiated
December 15, 2014
Reported by FDA
January 14, 2015
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11

by Actavis Elizabeth LLC

Reason
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Recall initiated
December 15, 2014
Reported by FDA
January 14, 2015
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.

by Actavis Elizabeth LLC

Reason
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Recall initiated
December 15, 2014
Reported by FDA
January 14, 2015
Distribution
Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.

by Right Value Drug Stores, Inc.

Reason
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Recall initiated
December 12, 2014
Reported by FDA
January 14, 2015
Distribution
KS, MO, and TX.

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11

by Hospira Inc.

Reason
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Recall initiated
December 22, 2014
Reported by FDA
January 14, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Recall initiated
December 9, 2014
Reported by FDA
January 14, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977

by Par Pharmaceutical Inc.

Reason
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Recall initiated
November 24, 2014
Reported by FDA
January 14, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

by Qualitest Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Recall initiated
December 22, 2014
Reported by FDA
January 14, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.

by Aurobindo Pharma USA Inc

Reason
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Recall initiated
October 17, 2014
Reported by FDA
January 14, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY

by One and Zen

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Recall initiated
November 20, 2014
Reported by FDA
January 7, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN

by Tropichem Research Labs, Inc.

Reason
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Recall initiated
December 17, 2014
Reported by FDA
January 7, 2015
Distribution
NY and IN.

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.