More than 25,000 bottles of the prescription blood pressure medication chlorthalidone have been recalled nationwide because the tablets failed quality standards for how they dissolve after being taken.
The Food and Drug Administration (FDA) classified the recall as Class II, meaning use of the product may cause temporary or medically reversible adverse health consequences, or that the risk of serious adverse health consequences is remote.
What medication was recalled?
The recalled medication is chlorthalidone tablets (25 mg), a prescription diuretic commonly used to treat high blood pressure and fluid retention. The recall affects chlorthalidone tablets manufactured by Inventia Healthcare Limited in Ambernath, India, and distributed nationwide by Rising Pharma Holdings, Inc.
The recalled tablets failed to meet dissolution specifications, according to the FDA. In plain terms, this means the tablets may not dissolve properly after being taken. Dissolution testing helps ensure that a medication breaks down and releases its active ingredient as intended, allowing the body to absorb it properly.
The recalls were initiated voluntarily by the manufacturer.
Which products are affected?
The recalls involve the following products distributed nationwide in the United States:
Chlorthalidone tablets, USP, 25 mg
100-tablet bottles
NDC: 64980-599-01Lot number: RISA24001Expiration date: April 2027
1,000-tablet bottles
NDC: 64980-599-10Lot number: RISB24002Expiration date: April 2027
Approximately 11,460 bottles are included in this part of the recall.