Shimoga Chemicals: Clomiphene Citrate Usp Active Pharmaceutical Ingredient (cas : 50-41-9), Net Weight A)1 Kg

Recall Summary Shimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient in three package sizes (1 kg, 500 g, and 100 g) due to manufacturing process deviations that don't meet required standards. The affected product was distributed to California and Florida. This is a prescription-only ingredient used in pharmaceutical manufacturing, not a finished consumer medication.

Recalling firm

Shimoga Chemicals

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

cGMP deviations

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-05-19

Status

Ongoing

Areas affected

CA, FL

Distribution

CA & FL only

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/0f4e3089-a7a3-4472-8f1b-0a912751047f