FDA recall record

Shimoga Chemicals Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) recall — FDA D-0691-2026

cGMP deviations

Class IIclassification
D-0691-2026official record ID
Jul 15, 2026report date

Recall record at a glance

Official recordD-0691-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmShimoga Chemicals
Report dateJul 15, 2026
Recall initiation dateMay 19, 2026
QuantityN/A
LocationSangli, N/A, India

Official product 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.

Why the product was recalled

cGMP deviations

Distribution information

CA & FL only

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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