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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 17,561–17,580 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.

by Physicians Total Care, Inc.

Reason
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Recall initiated
April 8, 2011
Reported by FDA
December 19, 2012
Distribution
VA

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Drug Recall Terminated Historical recordClass III

Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.

by Physicians Total Care, Inc.

Reason
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Recall initiated
April 8, 2011
Reported by FDA
December 19, 2012
Distribution
VA

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Drug Recall Terminated Historical recordClass III

Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.

by Physicians Total Care, Inc.

Reason
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Recall initiated
April 8, 2011
Reported by FDA
December 19, 2012
Distribution
VA

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Drug Recall Terminated Historical recordClass II

traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Recall initiated
November 5, 2012
Reported by FDA
December 12, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01

by Genentech Inc

Reason
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Recall initiated
September 20, 2012
Reported by FDA
December 12, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01

by Genentech Inc

Reason
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Recall initiated
September 20, 2012
Reported by FDA
December 12, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.

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

Reason
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Recall initiated
November 21, 2012
Reported by FDA
December 12, 2012
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

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Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.300 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.137 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.125 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.112 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Thyro-Tab 0.088 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including 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
cGMP Deviations; does not meet in process specification requirements
Recall initiated
July 9, 2012
Reported by FDA
December 12, 2012
Distribution
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

View recall →

Drug Recall Terminated Historical recordClass III

Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.

by Ferring Pharmaceuticals Inc

Reason
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Recall initiated
August 23, 2012
Reported by FDA
December 12, 2012
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.