Westminster Pharmaceuticals recalls
FDA enforcement reports naming Westminster Pharmaceuticals Llc as the recalling firm.
- Recall reports
- 10
- Class I (serious)
- 5
- Most recent report
- Aug 20, 2025
- Aug 20, 2025Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata…Drug · Westminster Pharmaceuticals LLCCGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.Class II
- Aug 20, 2025Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renat…Drug · Westminster Pharmaceuticals LLCCGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.Class II
- Dec 19, 2018Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceutic…Drug · Westminster Pharmaceuticals LlcCGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.Class II
- Dec 19, 2018Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuti…Drug · Westminster Pharmaceuticals LlcCGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.Class II
- Dec 19, 2018Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuti…Drug · Westminster Pharmaceuticals LlcCGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.Class II
- Aug 29, 2018Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottl…Drug · Westminster Pharmaceuticals LLCFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished prod…Class I
- Aug 29, 2018Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bot…Drug · Westminster Pharmaceuticals LLCFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished prod…Class I
- Aug 29, 2018Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count…Drug · Westminster Pharmaceuticals LLCFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished prod…Class I
- Aug 29, 2018Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bot…Drug · Westminster Pharmaceuticals LLCFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished prod…Class I
- Aug 29, 2018Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bott…Drug · Westminster Pharmaceuticals LLCFailed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished prod…Class I