FDA recall D-0691-2026

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 for recall

cGMP deviations

Distribution

CA & FL only

Key facts

Status

Ongoing

Initiation date

2026-05-19

Report date

2026-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sangli, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0691-2026