FDA classifies Inventia’s chlorthalidone recall as Class II after dissolution failures
The FDA has classified a nationwide recall of over 25,000 bottles of chlorthalidone 25 mg tablets as Class II, citing failures in dissolution specifications that may impair drug absorption. Manufactured by India-based Inventia Healthcare Limited, the affected batches were distributed across the United States. Patients are advised to consult their healthcare providers before discontinuing the medication, as stopping treatment may pose greater risks than continuing use of the recalled product.
Key points
- Inventia Healthcare Limited voluntarily recalled 11,460 bottles on June 5 and 13,567 bottles on September 3, 2026, due to improper dissolution.
- The FDA designated both recalls as Class II, indicating potential for temporary or medically reversible adverse health consequences.
- Affected batches include codes RISA24001, RISB24002, and RISA24002, with an expiration date of April 2027.
- Chlorthalidone is a diuretic used to treat hypertension and reduce fluid retention in heart, kidney, or liver disease.
- The FDA advises patients to continue taking the medication unless instructed otherwise by a healthcare provider, as abrupt discontinuation may be harmful.
Background
This is the second recall for chlorthalidone 25 mg tablets in three months, following a similar issue with Rising Pharma Holdings in June 2026. Recent studies emphasize that consistent adherence to blood pressure medications is critical for reducing cardiovascular risk, with patients taking at least 80% of prescribed doses showing an 11% lower risk of major events. Additionally, dietary adjustments, such as increasing potassium intake while reducing sodium, may support blood pressure control alongside medication.
How outlets are covering it
USA TODAY and Newsday highlight the FDA’s Class II classification and the total volume of recalled bottles, emphasizing the importance of patient consultation. News4JAX provides specific NDC and batch details, noting the voluntary nature of the recall. Good Housekeeping focuses on the FDA’s elevation of the recall status, while all sources agree on the dissolution issue as the primary cause. No significant disagreements exist among the outlets, but USA TODAY and Newsday provide broader context on the health implications, whereas News4JAX offers more technical product details.
Why it matters
The recall affects a widely used blood pressure medication, potentially impacting thousands of patients nationwide. Improper dissolution could lead to inadequate drug absorption, compromising blood pressure control and increasing cardiovascular risk. The FDA’s Class II classification underscores the need for patient vigilance and healthcare provider guidance to ensure safe medication use.
What to watch
Patients should check their medication batches against the recalled codes and consult their healthcare providers for alternatives. The FDA may continue monitoring the situation, and Inventia Healthcare Limited is expected to address the dissolution issues in future production. Healthcare providers can report adverse events to the FDA’s MedWatch program.
- Blood pressure medication recalled nationwide. See affected drug USA Today
- Blood pressure medication recalled nationwide after failing FDA dissolution testing wusa9.com
- FDA Announces New Nationwide Blood Pressure Medication Recall Good Housekeeping
- Drug company recalls blood pressure medication chlorthalidone Newsday
- Thousands of bottles of blood pressure medication recalled nationwide News4JAX
Want the full story? Read the original reporting
Read on USA Today