FDAFDA recall D-0691-2026 · Jul 15, 2026
Shimoga Chemicals: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) recall
Recall found
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- N/A
- Distribution
- CA & FL only
- Recalling firm
- Shimoga Chemicals, Sangli, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-19
Source: openFDA enforcement record D-0691-2026 · search recall number D-0691-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.