FDA recall, , Moderate risk
Shimoga Chemicals Clomiphene Citrate Active Pharmaceutical Ingredient
Clomiphene Citrate USP Active Pharmaceutical Ingredient has cGMP deviations.
Summary by Recall Canary from the FDA notice
What happened
Shimoga Chemicals of Sangli, India, recalled Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS: 50-41-9) due to cGMP deviations. The recall began May 19, 2026, and was added to the FDA's Enforcement Report on July 7, 2026, with classification on July 15, 2026. The product was distributed only in California and Florida.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
An NDC (National Drug Code) is usually printed on the drug's label.
Clomiphene Citrate USP Active Pharmaceutical Ingredient
- NDC
- 84849-000-01
- 84849-000-02
- 84849-000-03
- Lot code
- 004
- 24-25
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
- Company
- Shimoga ChemicalsSangli, India
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99232
- Recall number
- D-0691-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA · In FDA's weekly enforcement report
Summary updated
