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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

40

Past Year

0

Class I (Serious)

3

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 1–20 of 40 recalls

Hydrocortisone Otic Solution (Taro) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

FDAAug 7, 2024Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Hydrocortisone Acetic Acid Otic Solution (Taro) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

FDANov 6, 2023Nationwide• Taro Pharmaceuticals Inc.

Clotrimazole Betamethasone Cream (Taro) – content uniformity (2022)

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Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Class IIILow

FDAFeb 25, 2022IN, NY• Taro Pharmaceuticals U.S.A., Inc.

Clobetasol Ointment (Taro) – Bacterial Contamination (2021)

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

FDADec 15, 2021Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Nortriptyline HCl Capsules (Taro) – CGMP Deviation (2021)

CGMP deviations.

Class IIModerate

FDAJan 8, 2021Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Best Choice Clotrimazole Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

CVS Health Athlete's Foot Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Kaiser Permanente Clotrimazole Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

TopCare Athlete's Foot Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Kroger Athlete's Foot Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Athlete's Foot Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Equate Athlete's Foot Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Kroger Jock Itch Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

RiteAid Ringworm Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Athlete's Foot Cream (Taro) – Impurity Specification (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Clobetasol Propionate Cream (Taro) – Content Uniformity Issue (2020)

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

FDAJul 20, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Phenytoin Suspension (Taro) – Resuspension Problems (2020)

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

FDAFeb 7, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Lamotrigine 100mg Tablets (Taro Pharmaceuticals) – Cross Contamination (2019)

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

FDADec 20, 2019Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Children's Ibuprofen Suspension (Taro) – foreign substance (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.

Children's Ibuprofen Suspension (Taro) – manufacturing debris (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.