Why it was recalled
cGMP deviations
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
CA & FL only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0691-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 19, 2026
- FDA report date
- Jul 15, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shimoga Chemicals
Original FDA data
Every field from FDA enforcement report D-0691-2026, exactly as published.
Show all FDA fields
- City
- Sangli
- Status
- Ongoing
- Country
- India
- Event ID
- 99232
- Address
- W57 A Shimoga Chemicals, Kupwad Midc
- Code information
- 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.
- Report date
- Jul 15, 2026
- Product type
- Drugs
- Recall number
- D-0691-2026
- Classification
- Class II
- Recalling firm
- Shimoga Chemicals
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- CA & FL only
- Recall initiation date
- May 19, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2026