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Taro Pharmaceuticals U.S.A., Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20121
20131
20142
20151
20162
20173
20184
20195
202013
20211
20222
20241
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FDA Recall Terminated Historical recordClass II

Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.

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

Reason
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Published
November 21, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3

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

Reason
Failed Content Uniformity Specifications
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

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

Reason
Cross contamination with other products: traces of Dapsone were found in the finished product.
Published
November 1, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3

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

Reason
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Published
May 24, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532

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

Reason
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Published
April 26, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC

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

Reason
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Published
November 16, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.

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

Reason
Subpotent Drug
Published
June 8, 2016
Distribution
U.S. Including: CA, CT, MA, MD, NY, NJ,…

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FDA 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.
Published
February 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.

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

Reason
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Published
November 5, 2014
Distribution
Multiple states

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FDA Recall Terminated Historical recordClass III

Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.

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

Reason
Failed Content Uniformity Specifications.
Published
September 24, 2014
Distribution
United States including: OH, HI, NH, MS,…

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FDA Recall Terminated Historical recordClass III

Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.

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

Reason
Subpotent. drug
Published
December 18, 2013
Distribution
Nationwide

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FDA 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.
Published
December 12, 2012
Distribution
Nationwide

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This page lists recalls that name Taro Pharmaceuticals U.S.A., Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.