CLASS II ONGOING Drug recall · Reported 15 Jul 2026 · FDA Enforcement Report

Clomiphene Citrate USP Active Pharmaceutical Ingredient recalled

Shimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), distributed in California, Florida. The recall was initiated on 19 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0691-2026
FDA event ID
99232
Recalling firm
Shimoga Chemicals, Sangli, N/A
Classification
Class II
Status
Ongoing
Recall initiated
19 May 2026
FDA classified
15 Jul 2026
Reported
15 Jul 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

19 May 2026Recall initiated by company
15 Jul 2026Classified by FDA+57 days
15 Jul 2026Published in enforcement report+0 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP deviations

Product as listed by the FDA

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.

Where it was distributed

CA & FL only

CaliforniaFlorida

Questions about this recall

Why was it recalled?

cGMP deviations

Which lots are affected?

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.

Where was it sold?

CA & FL only

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.