Chlorthalidone Tablets Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for chlorthalidone tablets, USP, 25 mg. The affected batch has been identified as Lot RISA24002 (expires April 2027), containing 13 567 bottles.
• The recall was initiated by Inventia Healthcare, Ltd due to the product’s failure to meet dissolution specifications, 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.
• Chlorthalidone is used to treat hypertension and fluid retention.

The FDA has issued a Class II recall for chlorthalidone tablets, USP, 25 mg, affecting 13 567 bottles. This product is manufactured and being recalled by Inventia Healthcare, Ltd based in Kalyan, India. The recall was initiated on September 3, 2026, and received a Class II classification on September 17, 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 after the product failed to meet dissolution specifications. The affected product is Lot RISA24002, which will expire in April 2027. Inventia Healthcare sent out a public notice via letter; no press release has been issued for this recall.

Chlorthalidone is a prescription medication used to treat hypertension and fluid retention by decreasing the amount of water in the body and increasing the flow of urine. Pharmacists should identify and quarantine Lot RISA24002, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 23, 2026. Accessed September 24, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222515