Inventia Healthcare Limited initiated a voluntary recall of 11,460 bottles of Chlorthalidone Tablets USP, 25 mg on June 5 after the medication failed dissolution specifications, meaning the tablets may not break down correctly in the body.
Rising Pharma Holdings Inc., headquartered in East Brunswick, New Jersey, distributed the affected product, which came in both 100-count and 1,000-count bottle sizes. The affected lots are batch RISA24001 and batch RISB24002, both carrying an April 2027 expiration date.
Chlorthalidone is a diuretic prescribed to treat high blood pressure and fluid retention caused by conditions including congestive heart failure, kidney disease, and liver disease.
As of the time of reporting, the recall lacked both an FDA classification and any accompanying agency press release. Questions about what health consequences patients might face from the affected tablets have gone unanswered by the agency, according to People.
A dissolution failure indicates that during regulatory testing, the tablets did not disintegrate as required — a problem that can compromise how much of the active ingredient actually reaches a patient's system, according to Cardiovascular Business.
Anyone concerned that their prescription may be part of the recall is encouraged to reach out to a pharmacist or doctor before making any decisions. Abruptly discontinuing a prescribed blood pressure drug without professional guidance is not advisable, according to Local12.
This is the second blood pressure medication recalled within a month for the same reason. The earlier action, dated May 5, targeted 15,696 bottles of Amlodipine and Olmesartan Medoxomil Tablets at a 5mg/40mg dose in 30-count packaging, pulled for the same dissolution-related failure. Ascend Laboratories, LLC, of Parsippany, New Jersey handled U.S. distribution of that product, which was made by Alkem Laboratories Ltd. in India; those bottles carry an expiration date of Oct. 31, 2027.