D-0691-2026 Class II Ongoing

Recalled by Shimoga Chemicals — Sangli, N/A

FDA drug recall D-0691-2026 was initiated by Shimoga Chemicals on May 19, 2026 and is designated Class II. Reason for recall: cGMP deviations The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
July 15, 2026
Initiation Date
May 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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

Distribution Pattern

CA & FL only

Code Information

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.