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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 17,541–17,560 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason
Lack of Assurance of Sterility
Recall initiated
September 26, 2012
Reported by FDA
January 9, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason
Non-Sterility
Recall initiated
September 26, 2012
Reported by FDA
January 9, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason
Non-Sterility
Recall initiated
September 26, 2012
Reported by FDA
January 9, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason
Non-Sterility
Recall initiated
September 26, 2012
Reported by FDA
January 9, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason
Non-Sterility
Recall initiated
September 26, 2012
Reported by FDA
January 9, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.

by Abbott Laboratories

Reason
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Recall initiated
December 4, 2012
Reported by FDA
January 9, 2013
Distribution
US Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01

by Hospira Inc.

Reason
Presence of Particulates; may contain glass particles
Recall initiated
October 25, 2012
Reported by FDA
January 9, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom

by F. Hoffmann-LaRoche Ltd.

Reason
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Recall initiated
September 5, 2012
Reported by FDA
January 2, 2013
Distribution
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.

View recall →

Drug Recall Terminated Historical recordClass II

Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR

by Alara Pharmaceutical Co

Reason
Subpotent; 15 month stability
Recall initiated
October 29, 2012
Reported by FDA
January 2, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
Subpotent; 9-month stability interval
Recall initiated
July 25, 2012
Reported by FDA
January 2, 2013
Distribution
Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.

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Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA

by Lloyd Inc. of Iowa

Reason
Subpotent; 9-month stability interval
Recall initiated
July 25, 2012
Reported by FDA
January 2, 2013
Distribution
Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
Subpotent; 9-month stability interval
Recall initiated
July 25, 2012
Reported by FDA
January 2, 2013
Distribution
Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
Subpotent; 9-month stability interval
Recall initiated
July 25, 2012
Reported by FDA
January 2, 2013
Distribution
Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.

by Hospira, Inc.

Reason
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Recall initiated
October 4, 2012
Reported by FDA
December 26, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.

by Genentech, Inc.

Reason
Short Fill: some bottles contained less than 120-count per labeled claim.
Recall initiated
September 27, 2012
Reported by FDA
December 26, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

by Hospira, Inc.

Reason
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Recall initiated
November 21, 2012
Reported by FDA
December 26, 2012
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.

by Bracco Diagnostic Inc

Reason
Presence of Particulate Matter; potential for charcoal particulates
Recall initiated
August 14, 2012
Reported by FDA
December 26, 2012
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8

by Johnson & Johnson

Reason
Superpotent (Single Ingredient Drug): salicylic acid
Recall initiated
December 4, 2012
Reported by FDA
December 26, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

by Watson Laboratories Inc

Reason
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Recall initiated
December 13, 2012
Reported by FDA
December 26, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.

by Physicians Total Care, Inc.

Reason
Presence of Particulate Matter: glass delamination
Recall initiated
October 4, 2010
Reported by FDA
December 26, 2012
Distribution
PA, CA

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.