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

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS

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 24, 2026 at 12:00 AM UTC.

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