Aurobindo Pharma USA Inc Recalls

All product recalls associated with Aurobindo Pharma USA Inc.

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Recall Summary

Total Recalls

23

Past Year

1

Class I (Serious)

1

Most Recent

May 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 1–20 of 23 recalls

Acetaminophen Tablets (Aurobindo) - Tablet Discoloration (2025)

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Class IIModerate

FDAMay 22, 2025Nationwide• Aurobindo Pharma USA Inc

Nebivolol Tablets 2.5mg (Aurobindo) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Class IIModerate

FDADec 6, 2024Nationwide• Aurobindo Pharma USA Inc

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Acetaminophen (Aurobindo) – Missing Label (2024)

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

Class IHigh

FDAJul 11, 2024NJ, NY, PA• Aurobindo Pharma USA Inc

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

Class IIModerate

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

Class IIModerate

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Amlodipine Valsartan Tablets (Aurobindo) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Amlodipine Valsartan Tablets (Aurobindo) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA trace amounts (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan/HCTZ Tablets (Aurobindo) – NDEA impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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Aurobindo Pharma USA Inc Recalls

Recall Summary

Acetaminophen Tablets (Aurobindo) - Tablet Discoloration (2025)

Nebivolol Tablets 2.5mg (Aurobindo) – Nitrosamine Impurity (2024)

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

Acetaminophen (Aurobindo) – Missing Label (2024)

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

Amlodipine Valsartan Tablets (Aurobindo) – NDEA Impurity (2018)

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

Amlodipine Valsartan Tablets (Aurobindo) – NDEA Impurity (2018)

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

Valsartan Tablets (Aurobindo) – NDEA contamination (2018)

Valsartan Tablets (Aurobindo) – NDEA trace amounts (2018)

Valsartan/HCTZ Tablets (Aurobindo) – NDEA impurity (2018)