Clomiphene Citrate Recalled Due to CGMP Deviations

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for clomiphene citrate, 1 kg, 500 g, 100 g. The affected batches have been identified as Lots CC/004/24-25 (expires September 2029), CC/005/24-25 (expires November 2029), CC/009/24-25 (expires January 2030), and CC0032526 and CC0442526 (expire August 2030).
• The recall was initiated by Shimoga Chemicals due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Clomiphene is used as a fertility medicine to increase a woman’s chances of getting pregnant.

The FDA has issued a Class II recall for clomiphene citrate, 1 kg, 500 g, 100 g. This product is being recalled by Shimoga Chemicals based in Sangli, India. The recall was initiated on May 19, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to CGMP deviations. This deficiency affects Lots CC/004/24-25 (expires September 2029), CC/005/24-25 (expires November 2029), CC/009/24-25 (expires January 2030), and CC0032526 and CC0442526 (expire August 2030). Shimoga Chemicals sent out a public notice via letter; no press release has been issued for this recall.

Clomiphene is a prescription medication used to increase a woman’s chances of getting pregnant by prompting ovulation. Pharmacists should identify and quarantine the affected Lots, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 15, 2026. Accessed July 15, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221115