Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) recall
FDA recall D-0691-2026 · initiated May 19, 2026
Shimoga Chemicals recalled Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) in May 2026 — an FDA Class II recall (D-0691-2026) because cGMP deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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.
- Recalling company
- Shimoga Chemicals
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- CA & FL only
- Initiated
- May 19, 2026
- FDA report date
- Jul 15, 2026
Frequently asked
- Was Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) recalled?
- Shimoga Chemicals recalled Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) in May 2026 — an FDA Class II recall (D-0691-2026) because cGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) recalled?
- Per the FDA enforcement record, the reason for recall D-0691-2026 was: cGMP deviations
- Is a recalled Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9) are affected?
- Distributed: CA & FL only. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0691-2026.