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Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. Recalls

All product recalls associated with Mylan Pharmaceuticals Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Feb 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 41–60 of 79 recalls

Loxapine Capsules (Mylan) – Manufacturing Deviation (2018)

CGMP Deviations

Class IIModerate

FDAApr 24, 2018Nationwide• Mylan Pharmaceuticals Inc.

Bupropion HCL Tablets (Mylan) – Impurity Specifications Failure (2017)

Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.

Class IIILow

FDANov 3, 2017Nationwide• Mylan Pharmaceuticals Inc.

Montelukast Sodium Granules (Mylan) – Impurity Specification (2017)

Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

1 234

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Class III

Low

FDAMay 9, 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.

Atorvastatin Calcium Tablets 20mg (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 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.

Norethindrone Acetate Tablets (Mylan) – chemical contamination (2017)

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Class IIILow

FDAJan 30, 2017Nationwide• Mylan Pharmaceuticals Inc.