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Zydus Pharmaceuticals USA Inc

Zydus Pharmaceuticals USA Inc Recalls

All product recalls associated with Zydus Pharmaceuticals USA 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 2121–2140 of 4747 recalls

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination Risk (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class II

1...105 106107108 109...238

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Moderate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination Risk (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Anastrozole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Pramipexole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH Creatine Kinase (CK_L) Reagent, Product Code ...

A steady upward trend in blank (u) absorbance was observed

FDAMay 3, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product C...

A steady upward trend in blank (u) absorbance was observed

FDAMay 3, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Losartan Potassium 100mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 50mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 25mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 100mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 50mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Ketorolac Injection (Sagent Pharmaceuticals) – Microbial Growth (2019)

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Class IIModerate

FDAApr 30, 2019Nationwide• Sagent Pharmaceuticals Inc

Losartan Potassium Tablets (Preferred Pharmaceuticals) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAApr 30, 2019CA, GA, IN +1 more• Preferred Pharmaceuticals, Inc