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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 15,361–15,380 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass II

Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 .

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass II

Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass II

Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass II

Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass II

Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass II

Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1.

by Terra-Medica Inc.

Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

View recall →

Drug Recall Terminated Historical recordClass III

QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.

by Teva Pharmaceuticals USA

Reason
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Recall initiated
February 11, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01

by American Health Packaging

Reason
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Recall initiated
January 31, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01

by American Health Packaging

Reason
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Recall initiated
January 31, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Recall initiated
January 27, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Recall initiated
January 27, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13

by Viiv Healthcare Company

Reason
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Recall initiated
February 11, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Recall initiated
March 4, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Recall initiated
March 4, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Recall initiated
March 4, 2014
Reported by FDA
April 9, 2014
Distribution
Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass III

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Recall initiated
January 31, 2014
Reported by FDA
April 2, 2014
Distribution
Nationwide and Puerto Rico

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.