The FDA has initiated a recall of over 11,000 bottles of Chlorthalidone Tablets USP, 25 mg, due to concerns about their effectiveness.
The US Food and Drug Administration (FDA) has announced a nationwide recall of more than 11,000 bottles of a blood pressure medication after tests found the drug may not work as intended.
The recall affects 11,460 bottles of Chlorthalidone Tablets USP, 25 mg, a medication commonly prescribed to treat high blood pressure. According to the FDA notice, the product failed to meet required dissolution specifications, raising concerns that patients may not receive the proper dose or therapeutic effect from the medication.
Dissolution testing measures how effectively a drug dissolves and releases its active ingredients once consumed. If a medication fails these standards, it may be less effective at controlling the condition it is intended to treat.
Chlorthalidone is widely used to manage hypertension, a condition that increases pressure on the arteries and can raise the risk of heart disease, stroke and other cardiovascular complications.
Full List of Lots Included in Chlorthalidone Recall
The US Food and Drug Administration (FDA) has identified specific lot numbers included in the nationwide recall of Chlorthalidone Tablets USP, 25 mg, which was initiated after the medication failed dissolution specifications and may be less effective than intended.
The recall covers the following lots:
- RISA24001 (100-count bottles)
- RISB24002 (1,000-count bottles)
Both lots are affected by the quality issue that prompted the recall. The impacted products carry an expiration date of April 2027.
The medication was manufactured by Inventia Healthcare Limited in India and distributed in the United States by Rising Pharma Holdings, Inc..
The latest action follows a similar recall issued in May involving Amlodipine and Olmesartan Medoxomil tablets, which were also found to have failed dissolution specifications. More than 15,000 bottles of that medication were recalled.