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FDAClass II · Drug · Recalled July 15, 2026
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS recall — Shimoga Chemicals
Hazard: cGMP deviations
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0691-2026
- Brand
- Shimoga Chemicals
- Classification
- Class II
- Units affected
- N/A
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
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.
Affected products
Companies & origin
- Recalling firm location
- Sangli, N/A, India
- Firm address
- W57 A Shimoga Chemicals, Kupwad Midc, N/A, N/A
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- Distribution
- CA & FL only
- Firm notified the public via
- Letter
- FDA event ID
- 99232
- Recall initiated
- May 19, 2026
- FDA classified
- July 15, 2026
- FDA report date
- July 15, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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