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Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. Recalls

All product recalls associated with Sun Pharmaceutical Industries, Inc..

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

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 2721–2740 of 4747 recalls

Olanzapine Tablets 2.5mg (Sun Pharmaceutical) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Class IIILow

FDAMar 22, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Olanzapine Tablets 7.5mg (Sun Pharmaceutical) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Class IIILow

FDAMar 22, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Atorvastatin Calcium Tablets 20mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

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Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Atorvastatin Calcium Tablets 10mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Atorvastatin Calcium Tablets 40mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Atorvastatin Calcium Tablets 80mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

CLENZIderm Acne Treatment System (Valeant) – Product Discoloration (2017)

Discoloration.

Class IIILow

FDAMar 20, 2017Nationwide• Valeant Pharmaceuticals North America LLC

CLENZIderm Pore Therapy (Valeant) – Product Discoloration (2017)

Discoloration.

Class IIILow

FDAMar 20, 2017Nationwide• Valeant Pharmaceuticals North America LLC

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.

Divalproex Sodium Tablets (Zydus) – Failed Dissolution (2017)

Failed Dissolution Specifications; 9 month long term stability

Class IIModerate

FDAMar 15, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Testosterone Cypionate Injection (Sun Pharmaceutical) – Particulate Matter (2017)

Presence of Particulate Matter

Class IIModerate

FDAMar 15, 2017Nationwide• Sun Pharmaceutical Industries, Inc.