Karmactive Staff
The U.S. Food and Drug Administration has published two enforcement report entries, identified as D-0610-2026 and D-0852-2026, that involve Chlorthalidone Tablets USP 25 mg. The entries name Rising Pharma and Inventia in connection with the product. Patients who take this medication should compare the lot details on their bottle with the information in this article before deciding what to do next.
The lots listed in the reports are RISA24001 and RISA24002, each in a 100-count package, along with RISB24002, which comes in a 1000-count package. Every listed lot carries an April 2027 expiration date. Tablets from these lots are light-yellow and round, with the imprint 103. In total, the enforcement entries cover 25,027 bottles.
The reports describe two test results that fell below their specifications. Dissolution testing measured 78% against an 80% specification, and potency testing measured 91.5% against a 92% specification. Dissolution describes how quickly a tablet releases its active ingredient under test conditions, while potency describes the amount of active ingredient relative to the labeled strength. These terms are defined here for general reference.
Enforcement report entries list identifying details such as lot numbers, expiration dates, and imprints, so that a reader can compare those details with the product in hand. The listed details are the lot number, the expiration date, and the imprint. A pharmacist can confirm whether all three match a specific bottle, which is more reliable than checking a single detail on its own.
Patients should not stop taking the medication without guidance from a clinician or pharmacist. A clinician or pharmacist can advise on the right next step for each individual. Patients who want to check whether their supply is affected should contact their pharmacist or prescriber for lot verification. The same contact can arrange a replacement where one is needed. Keeping the bottle and its label available during that conversation makes the lot check easier.
Questions about the difference between a lot-level listing and a general product warning are best directed to a pharmacist, who can explain how the listing applies to a particular prescription. Readers who want related reading on other health topics can start with related reading, or continue with related reading on a separate subject.
More information about recall listings is available from the agency at FDA enforcement reports. Lot details and test results in this article are drawn from the enforcement report entries.
