The FDA has recalled 11,460 bottles of Chlorthalidone 25 mg after the tablets failed dissolution testing. The recall covers batches RISA24001 (100-tablet bottles) and RISB24002 (1,000-tablet bottles) with an April 2027 expiry; the product was made by Inventia Healthcare Limited and distributed by Rising Pharma Holdings. The agency has not yet specified health risks. This follows a May 5 national recall of 15,696 bottles of Amlodipine/Olmesartan for failed dissolution and low olmesartan content.
FDA Recalls 11,460 Bottles of Chlorthalidone 25 mg After Dissolution Failures — Second Blood-Pressure Drug Recall This Month
Pills pour out of a prescription medication bottleCredit: Getty
The U.S. Food and Drug Administration has announced a nationwide recall of 11,460 bottles of Chlorthalidone Tablets, USP, 25 mg after laboratory testing showed the product failed dissolution specifications.
What Was Recalled
The recall, announced on June 5, covers two container types with an April 2027 expiration date: 100-tablet bottles labeled as batch RISA24001 and 1,000-tablet bottles labeled as batch RISB24002. The tablets were manufactured by Inventia Healthcare Limited (India) and distributed in the U.S. by Rising Pharma Holdings, Inc., of East Brunswick, New Jersey, according to the FDA.
Why It Matters
"Failed dissolution specifications" means the tablets did not dissolve as expected under test conditions, which can affect how the active ingredient is released and absorbed. The FDA has not yet issued guidance on whether taking the affected tablets poses immediate health risks.
"If you have high blood pressure, the force of the blood pushing against the artery walls is consistently too high. The heart has to work harder to pump blood." — Mayo Clinic
Context: A Second Recent Recall
This is the second nationwide blood-pressure drug recall in about a month. On May 5 the FDA recalled 15,696 bottles of Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg (30-count prescription bottles) because of failed dissolution specifications and olmesartan medoxomil content below specification limits. Those bottles were manufactured by Alkem Laboratories Ltd. (India), distributed by Ascend Laboratories, LLC (Parsippany, N.J.), and carried an Oct. 31, 2027 expiration date.
What Patients Should Do
- Check prescription bottles for batch numbers RISA24001 and RISB24002 and the April 2027 expiration date.
- If you have the affected product, stop taking it and contact your pharmacist or prescribing health care provider for guidance and possible replacement therapy.
- Follow instructions from the FDA and the distributing firms for returns or disposal, and consult the FDA recall notice for updates and contact information.
Patients with questions about potential health effects should contact their health care provider or local poison control center. The FDA and the distributing companies will typically provide additional guidance and recall return procedures on their websites.
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