India-based pharmaceutical manufacturer Inventia Healthcare Limited has initiated a voluntary nationwide recall of more than 13,000 bottles of blood pressure medication. The recall, announced following an FDA alert on September 17, 2026, was triggered by the product’s failure to meet established dissolution specifications.
Details of the Recalled Medication
The recall specifically impacts 25 mg Chlorthalidone tablets, which are used to treat hypertension and fluid retention. According to the FDA, the affected inventory consists of approximately 13,567 bottles, each containing 100 tablets.
Identification Information
- Product: Chlorthalidone Tablets, 25 mg
- Batch Number: RISA24002
- Expiration Date: April 2027
- Manufacturer: Inventia Healthcare Limited
FDA Class II Designation
The FDA has classified this as a Class II recall. This classification is used when a product may cause temporary or medically reversible adverse health consequences. The agency noted that the probability of serious harm from using these tablets remains remote.
Manufacturing Context
This is the company’s second significant recall this year. In June 2026, Inventia Healthcare recalled approximately 11,460 bottles of blood pressure medication due to similar quality control concerns regarding dissolution failures.
Guidance for Consumers
Patients taking Chlorthalidone should check their medication bottles for batch number RISA24002. If your bottle matches this number, do not stop taking the medication without consulting your healthcare provider. Your doctor can advise you on whether to return the medication to your pharmacy or if you need an alternative treatment plan to maintain blood pressure control.
Frequently Asked Questions
What is “dissolution failure”?
Dissolution testing measures how quickly a tablet breaks down in the body to release the drug. If a pill fails these tests, it may not be absorbed correctly, which can make the medication ineffective.
Is this recall dangerous?
The FDA has labeled this a Class II recall. While the product does not meet quality standards, the risk of serious or permanent health damage is considered low.
Should I stop taking my blood pressure medication?
No. Stopping blood pressure medication abruptly can cause dangerous spikes in blood pressure. Always speak with your physician or pharmacist before changing your medication regimen.
How do I check if my medication is affected?
Check the label on your bottle for the batch number RISA24002. If it matches, contact your pharmacy to arrange for a return or replacement.
Are other Inventia Healthcare products affected?
No. At this time, the recall is limited to the specific batch of 25 mg Chlorthalidone identified in the September 17, 2026, FDA alert.
