Shimoga Chemicals Clomiphene Citrate USP Active Pharmaceutical Ingredient Recall
Announced 2026-07-15 · FDA
Shimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient (Rx Only) due to cGMP deviations. The recall, conducted by the FDA, covers multiple lots distributed in California and Florida with expiration dates ranging from 2029 to 2030. The affected lots include CC/004/24-25, CC0032526, CC0442526, CC/005/24-25, and CC/009/24-25.
| Brand | Shimoga Chemicals |
|---|---|
| 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 | cGMP deviations |
| Severity | moderate |
| Units affected | N/A |
| Distribution | CA & FL only |
| Agency | FDA |
| Recall / campaign no. | 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. |
WHAT YOU SHOULD DO
- Do not use recalled lots of Clomiphene Citrate USP API.
- If you have affected lots, contact your supplier or Shimoga Chemicals to arrange return, replacement, or disposal according to local regulations.
- Check the recall notice for the exact lot numbers and expiration dates to identify affected items.
- If you have questions, contact the FDA or your supplier for guidance.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.