Drug recall D-0691-2026

Class II Ongoing reported Jul 15, 2026

Product

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.

Reason for recall

cGMP deviations

Lots and codes

Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.

Recall details

Recalling firm
Shimoga Chemicals, Sangli, N/A
Quantity
N/A
Distribution
CA & FL only
Type
Voluntary: Firm initiated
Recall initiated
May 19, 2026