Westminster Pharmaceuticals LLC Recalls

All product recalls associated with Westminster Pharmaceuticals LLC.

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Recall Summary

Total Recalls

10

Past Year

2

Class I (Serious)

5

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 1–10 of 10 recalls

Metoprolol Tablets 50mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Metoprolol Tablets 100mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Irbesartan Tablets 300mg (Westminster) – NDEA Trace Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Class IIModerate

FDAOct 29, 2018Nationwide• Westminster Pharmaceuticals Llc

Irbesartan Tablets 150mg (Westminster) – NDEA Trace Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Class IIModerate

FDAOct 29, 2018Nationwide• Westminster Pharmaceuticals Llc

Irbesartan Tablets (Westminster) – NDEA Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Class IIModerate

FDAOct 29, 2018Nationwide• Westminster Pharmaceuticals Llc

Levothyroxine Thyroid Tablets 1.5-Grain (Westminster) - Content Uniformity Failure (2018)

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Class IHigh

FDAAug 3, 2018Nationwide• Westminster Pharmaceuticals LLC

Levothyroxine Thyroid Tablets (Westminster) – Content Uniformity Fail (2018)

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Class IHigh

FDAAug 3, 2018Nationwide• Westminster Pharmaceuticals LLC

Levothyroxine Thyroid Tablets (Westminster) - Content Uniformity Failure (2018)

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Class IHigh

FDAAug 3, 2018Nationwide• Westminster Pharmaceuticals LLC

Levothyroxine Thyroid Tablets 2-Grain (Westminster) - Content Uniformity Failure (2018)

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Class IHigh

FDAAug 3, 2018Nationwide• Westminster Pharmaceuticals LLC

Levothyroxine Thyroid Tablets (Westminster) – Content Uniformity Fail (2018)

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Class IHigh

FDAAug 3, 2018Nationwide• Westminster Pharmaceuticals LLC

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Westminster Pharmaceuticals LLC Recalls

Recall Summary

Metoprolol Tablets 50mg (Westminster) - Nitrosamine Risk (2025)

Metoprolol Tablets 100mg (Westminster) - Nitrosamine Risk (2025)

Irbesartan Tablets 300mg (Westminster) – NDEA Trace Impurity (2018)

Irbesartan Tablets 150mg (Westminster) – NDEA Trace Impurity (2018)

Irbesartan Tablets (Westminster) – NDEA Impurity (2018)

Levothyroxine Thyroid Tablets 1.5-Grain (Westminster) - Content Uniformity Failure (2018)

Levothyroxine Thyroid Tablets (Westminster) – Content Uniformity Fail (2018)

Levothyroxine Thyroid Tablets (Westminster) - Content Uniformity Failure (2018)

Levothyroxine Thyroid Tablets 2-Grain (Westminster) - Content Uniformity Failure (2018)

Levothyroxine Thyroid Tablets (Westminster) – Content Uniformity Fail (2018)