Clomiphene Citrate USP Active Pharmaceutical Ingredient — Class II drug recall D-0691-2026
Ongoing recall by Shimoga Chemicals, reported 2026-07-15, distributed in CA, FL. cGMP deviations
| Recall number | D-0691-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimoga Chemicals, Sangli, N/A, India |
| Recall initiated | 2026-05-19 |
| Classified | 2026-07-15 |
| Reported by FDA | 2026-07-15 |
| Distributed | CA, FL |
| Reason classes | cgmp |
| NDC | 84849-0000-01, 84849-0000-02, 84849-0000-03 |
| Expiration dates | 2029-09-20, 2029-11-20, 2030-01-20, 2030-08-20 |
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.