FDA lists nationwide recall of over 11,000 bottles of blood pressure drug

The Food and Drug Administration announced a nationwide recall Thursday of 11,460 bottles of chlorthalidone tablets, USP, 25 mg, a blood pressure medication distributed by Rising Pharma Holdings Inc. of East Brunswick, New Jersey. The recall was initiated by Inventia Healthcare Limited after the tablets failed dissolution specifications, meaning they did not dissolve properly during testing, officials said.

The affected products carry an expiration date of April 2027, which helps identify the production timeframe involved in the recall. The FDA classified the recall as Class II, indicating that exposure to the medication may cause temporary or medically reversible adverse health consequences, officials said.

The recalled chlorthalidone tablets were distributed nationwide in 100-count and 1,000-count bottles, with batch numbers RISA24001 and RISB24002, respectively, according to the FDA notice reviewed by multiple news outlets.

The reason for the recall was a failure to meet dissolution specifications, meaning the tablets did not dissolve properly during testing, which could affect the release rate of the active ingredient. This failure may result in the medication being less effective or delivering an inconsistent dose to patients, according to the FDA and health news reports. The issue stems from a manufacturing quality control problem rather than contamination or labeling errors, sources confirmed.

Inventia Healthcare Limited, the manufacturer based in India, initiated the recall, and Rising Pharma Holdings Inc., located in East Brunswick, New Jersey, distributed the product in the United States. The recall began on June 5, 2026, with the FDA issuing a public notice dated June 12, 2026, stating that the affected bottles were being withdrawn from distribution nationwide. The recall specifically targets certain lots and package sizes rather than all chlorthalidone products, according to FDA records.

Patients who have the recalled medication are advised to check their bottles for the specified batch numbers and package sizes and to contact their pharmacist or healthcare provider for guidance. The FDA and health officials cautioned patients not to stop taking chlorthalidone abruptly without consulting a healthcare professional. Some reports noted that patients might return the recalled medication to the place of purchase, subject to individual retailer policies, but the FDA has not issued detailed public instructions beyond the recall announcement.

Chlorthalidone is a commonly prescribed blood pressure medication used to treat hypertension. The nationwide recall affects more than 11,000 bottles, with the precise figure reported as 11,460. The recall has been covered widely by consumer and health news outlets, which consistently identified the product and the dissolution failure as the core issues. Other blood pressure medication recalls, such as those involving bisoprolol fumarate/hydrochlorothiazide or spironolactone, are unrelated and involve different classifications and concerns.

The FDA continues to monitor the recall and its impact, with the affected products being removed from the market as of June 2026. Further updates or instructions may be issued as the situation develops, according to agency officials.