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 Lots RISA24001 and RISB24002 (expiration April 2027), affecting 11 460 bottles.
• The recall was initiated by Inventia Healthcare Limited due to failed dissolution specifications, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Chlorthalidone is used to treat high blood pressure and fluid retention.

The FDA has issued a Class II recall for chlorthalidone tablets, USP, 25 mg, affecting 11 460 bottles. This medication is manufactured, and being recalled, by Inventia Healthcare Limited in Ambernath, India. The recall was initiated on June 5, 2026, and received a Class II classification on June 22, 2026. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences or has a low chance of causing serious adverse health consequences.

The recall was initiated due to the product’s failure to meet dissolution specifications. This deficiency affects Lots RISA24001 and RISB24002, 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. It can also be used to treat fluid retention caused by congestive heart failure, cirrhosis, or kidney disease. Pharmacists should identify and quarantine Lots RISA24001 and RISB24002, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 24, 2026. Accessed June 24, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220914