Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

AvKARE

NDC code

50268-442-15

Origin

TN, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0224-2025

Other Irbesartan recalls

See all

Class II · Moderate risk Terminated Jul 18, 2022

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India…

Reason Failed Dissolution Specifications

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-447-90 D-1294-2022

Class II · Moderate risk Terminated Jul 18, 2022

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India…

Reason Failed dissolution specifications.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-448-90 D-1293-2022

Class II · Moderate risk Terminated Oct 12, 2021

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09)…

Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Lupin Pharmaceuticals Inc. NDC 68180-414-06 D-0090-2022

Class II · Moderate risk Terminated Oct 12, 2021

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09)…

Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Lupin Pharmaceuticals Inc. NDC 68180-413-06 D-0089-2022

Class II · Moderate risk Terminated Oct 12, 2021

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Lupin Pharmaceuticals Inc. NDC 68180-412-06 D-0088-2022