FDA Issues Class II Recall for Blood Pressure Medication, Impacting Over 13,000 Bottles

A significant recall has been announced for a commonly prescribed blood pressure medication, chlorthalidone, affecting over 13,500 bottles nationwide. The U.S. Food and Drug Administration (FDA) revealed that the recall was initiated by Inventia Healthcare Limited due to the tablets failing to meet critical lab dissolution specifications.

On September 3, 2026, the recall was voluntarily executed after lab tests showed that the 25 mg chlorthalidone tablets did not dissolve as expected. This failure in dissolution means that the medication may not release its active ingredient effectively, potentially compromising its therapeutic efficacy. Chlorthalidone is often used to manage high blood pressure and reduce fluid retention in patients.

This recall marks the second instance this year that Inventia has had to withdraw its 25 mg chlorthalidone tablets from the market. The first recall occurred on June 5, 2026, affecting an additional 11,460 bottles, bringing the total number of recalled bottles to 25,027 for both incidents. Both recalls share the same expiration date of April 2027.

The specific chlorthalidone tablets involved in the recent recall are light yellow, round, and flat, with “103” embossed on one side. The recalled batches include those under National Drug Code (NDC) 64980-599-01, which are packaged in 100-tablet bottles.

For patients currently prescribed chlorthalidone, it is essential to check if their medication is part of the recall. The FDA advises individuals to contact their pharmacy for assistance in determining whether their tablets are affected and to discuss possible replacements. Generally, for Class II recalls, patients can continue taking their medication unless specifically advised otherwise by the manufacturer.

Class II recalls indicate that while the use of the recalled medication may pose a risk of temporary health problems, severe harm is unlikely. As such, the FDA emphasizes that discontinuing medication without proper guidance may be more harmful than continuing to take the recalled product.

Patients can verify their medications by contacting their pharmacy, inquiring about the manufacturer, NDC, and batch numbers, and comparing this information with the recall details provided by the FDA.

Chlorthalidone is primarily utilized in the treatment of hypertension, either as a standalone treatment or in conjunction with other medications. It is also prescribed to manage swelling related to heart failure, liver conditions, and certain kidney disorders.

In light of these developments, patients are encouraged to stay informed and proactive regarding their health and medication management. The FDA continues to monitor the situation and will provide updates as necessary, emphasizing the importance of safe and effective medication practices.