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Taro Pharmaceuticals U.S.A., Inc.

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

All product recalls associated with Taro Pharmaceuticals U.S.A., Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Aug 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 40 recalls

Children's Ibuprofen Suspension (Taro) – particle risk (2019)

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Class IIModerate

FDASep 27, 2019Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Ibuprofen Oral Suspension (Taro) – plastic contamination (2019)

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Class IIModerate

FDASep 27, 2019Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Ibuprofen Oral Suspension (Taro) – plastic particles (2019)

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

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Class IIModerate

FDASep 27, 2019Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Children's Allergy Solution (Taro) – Impurity Limit Exceeded (2018)

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Children's Allergy Solution (Taro) – Impurity Limit Exceeded (2018)

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Children's 24 Hour Allergy (Taro Pharmaceuticals) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Clobetasol Propionate Cream 0.05% (Taro) – content uniformity issue (2017)

Failed Content Uniformity Specifications

Class IIILow

FDADec 21, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Fluocinonide Gel (Taro) – Cross Contamination (2017)

Cross contamination with other products: traces of Dapsone were found in the finished product.

Class IIILow

FDASep 20, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Nystatin Triamcinolone Cream (Taro) – content uniformity (2017)

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

Class IIModerate

FDAMar 28, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Fluocinonide Cream (Taro Pharmaceuticals) – Cross Contamination (2017)

Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

Class IIILow

FDAMar 17, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Desoximetasone Cream 0.25% (Taro) – Homogeneity Test Failure (2016)

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Class IIModerate

FDASep 13, 2016PR• Taro Pharmaceuticals, Inc.

Desoximetasone Cream 0.05% (Taro) – Homogeneity Test Failure (2016)

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Class IIModerate

FDASep 13, 2016PR• Taro Pharmaceuticals, Inc.

Dandruff Care System (Taro Pharmaceuticals) – Subpotent Active Ingredient (2016)

Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.

Class IIILow

FDAMay 26, 2016Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Topicort Cream (Taro) – Subpotent Drug (2016)

Subpotent Drug

Class IIILow

FDAMar 31, 2016CA, CT, MD +6 more• Taro Pharmaceuticals U.S.A., Inc.

Topicort Topical Spray (Taro Pharmaceuticals) – Impurity Specs (2015)

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

Class IIILow

FDAAug 5, 2015Nationwide• Taro Pharmaceuticals, Inc.

Children's Loratadine Syrup (Taro) – Blue plastic found (2014)

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

Class IIModerate

FDADec 30, 2014Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Carbamazepine Tablets (Taro Pharmaceuticals) – unauthorized sale (2014)

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.

Class IIILow

FDAOct 21, 2014IL, LA, OH• Taro Pharmaceuticals U.S.A., Inc.