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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 14,541–14,560 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall initiated
October 6, 2014
Reported by FDA
February 25, 2015
Distribution
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.

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Drug Recall Terminated Historical recordClass II

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86

by Sun Pharma Global Fze

Reason
Failed Dissolution Specifications: 6 month time point.
Recall initiated
January 21, 2015
Reported by FDA
February 18, 2015
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .

by Akorn, Inc.

Reason
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Recall initiated
January 28, 2015
Reported by FDA
February 18, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.

by AnazaoHealth Corporation

Reason
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Recall initiated
January 26, 2015
Reported by FDA
February 18, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Recall initiated
December 30, 2014
Reported by FDA
February 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

by Hospira Inc.

Reason
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Recall initiated
April 18, 2014
Reported by FDA
February 11, 2015
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

by Hospira Inc.

Reason
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Recall initiated
December 23, 2014
Reported by FDA
February 4, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Recall initiated
December 23, 2014
Reported by FDA
February 4, 2015
Distribution
Nationwide, United Arab Emirates, and Columbia

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Drug Recall Terminated Historical recordClass II

Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.

by Valeant Pharmaceuticals North America LLC

Reason
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Recall initiated
December 31, 2014
Reported by FDA
January 28, 2015
Distribution
Nationwide and Australia

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Drug Recall Terminated Historical recordClass II

LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Recall initiated
September 26, 2013
Reported by FDA
January 28, 2015
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Recall initiated
September 26, 2013
Reported by FDA
January 28, 2015
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144

by 3M Company/3m Espe Dental Products

Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Recall initiated
December 19, 2014
Reported by FDA
January 28, 2015
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Total parenteral nutrition various strengths

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

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Drug Recall Terminated Historical recordClass II

L-cysteine various strengths

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

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Drug Recall Terminated Historical recordClass II

Immune globulin g human various strengths

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

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Drug Recall Terminated Historical recordClass II

Diphenhydramine 50 mg/ml vials

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

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Drug Recall Terminated Historical recordClass II

Dehydrated alcohol vials

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

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Drug Recall Terminated Historical recordClass III

Deferoxamine 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

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Drug Recall Terminated Historical recordClass II

Magnesium sulfate various strengths in sodium chloride

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

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Drug Recall Terminated Historical recordClass II

Ranitidine various strengths in syringes

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

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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.