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Northwind Pharmaceuticals LLC

Northwind Pharmaceuticals LLC Recalls

All product recalls associated with Northwind Pharmaceuticals LLC.

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Recall Summary

Total Recalls

13

Past Year

1

Class I (Serious)

0

Most Recent

Aug 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 1–13 of 13 recalls

Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 20, 2025Nationwide• Northwind Pharmaceuticals LLC

BusPIRone Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class II

Moderate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Atorvastatin Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Tadalafil Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Doxazosin Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Tadalafil Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Valsartan 80mg (Northwind Pharmaceuticals) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018IN• Northwind Pharmaceuticals LLC

Valsartan 320mg (Northwind Pharmaceuticals) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018IN• Northwind Pharmaceuticals LLC

Valsartan 160mg (Northwind Pharmaceuticals) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018IN• Northwind Pharmaceuticals LLC

Valsartan HCTZ (Northwind Pharmaceuticals) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAJul 18, 2018IN• Northwind Pharmaceuticals LLC

Prednisone Tablet (Northwind) – Incorrect Labeling (2015)

Labeling: Not elsewhere classified. NDC number is incorrect on the container.

FDANov 10, 2015Nationwide• Northwind Pharmaceuticals LLC