Inventia Healthcare Ltd. has voluntarily recalled 13,567 bottles of chlorthalidone tablets nationwide after quality testing found that the medication did not dissolve properly, according to a Food and Drug Administration enforcement report. The recall began in September and covers bottles containing 100 tablets each at a strength of 25 milligrams.
Chlorthalidone is prescribed to treat high blood pressure and fluid retention. The recalled bottles carry National Drug Code 64980-599-01 and an expiration date of April 2027. Those identifiers distinguish the affected product from other medications or packaging that patients and pharmacies may have on hand.
The FDA classified the recall as Class II. Under the agency’s definition, that classification applies when use of a product may cause temporary or medically reversible health effects, or when the likelihood of serious health consequences is remote. The classification describes the agency’s assessment of potential risk; the account provided does not include details about reported injuries or specific patient outcomes.
This is the second recall of the same product this year related to how the tablets dissolve. In June, Inventia recalled more than 11,400 bottles for dissolution issues. The September action involves a larger number of bottles, although the information provided does not explain whether the two recalls cover different production batches or distribution channels.
Inventia Healthcare is based in India. Fox Business reported that it contacted the company for comment, but the account provided does not include a response. The FDA enforcement report identifies the number of bottles, dosage, packaging, expiration date and reason for the latest action.
For patients and health care providers, the central facts are the product identifiers and the reason for the recall. The available account does not say whether individuals should take any specific action, and it does not describe a change to the medication’s approved uses.