Inventia recalls 13,567 chlorthalidone bottles after lab failures

Inventia Healthcare Limited voluntarily recalled 13,567 bottles of chlorthalidone tablets on Sept. 3, according to a Food and Drug Administration enforcement report.

Evidence grade: Claim (no study cited) for health-risk estimates; the recall itself is documented in FDA enforcement reports. The FDA classified the action as Class II, while a June recall covered 11,460 bottles of the same medicine.

“The voluntary recalls cited are classified as Class II, at the retail level,” an FDA spokesperson told Healthline. A retail-level recall means a company is removing product from retail stores and pharmacy shelves, Ileana Elder, a branch chief in the FDA’s Office of Compliance, said in an FDA podcast cited by Healthline.

The September recall covers batch RISA24002 in 100-tablet bottles with NDC 64980-599-01, according to the FDA enforcement report. NDC means National Drug Code, the identifier used for drug products in the U.S.

The FDA report gives the reason as “Failed Dissolution Specifications,” a quality-test failure involving how a tablet releases its active ingredient. “If a medication does not dissolve at the expected rate, it may not be absorbed by the body as intended,” Cheng-Han Chen, a board-certified interventional cardiologist at MemorialCare Saddleback Medical Center, told Healthline.

“This can reduce the amount of medication that reaches the bloodstream and potentially decrease its effectiveness,” Chen said. Healthline identified chlorthalidone as a diuretic, often called a water pill, used for high blood pressure and excess fluid retention.

The new action follows Inventia’s June 5 recall of 11,460 bottles. Together, the two Class II recalls cover 25,027 bottles across three batches, all expiring in April 2027, according to FDA enforcement reports cited by Healthline.

The June recall involved batch RISA24001 in 100-tablet bottles with NDC 64980-599-01 and batch RISB24002 in 1,000-tablet bottles with NDC 64980-599-10. The affected tablets are light yellow, round and flat, with “103” on one side and no marking on the other, according to the drug label cited by Healthline.

A notice from Rising Pharma Holdings about the June recall said testing at the 18-month mark found chlorthalidone content at 91.5% of the labeled amount, below a 92% approved minimum. The same notice said average dissolution was 78%, below an 80% standard.

The September FDA enforcement report does not say how the recalled tablets failed their dissolution specification. Healthline said it contacted the companies for more information on the September recall but had not received a response before publication, and the FDA referred further questions to the companies.

For people whose medication is part of the recall, Chen told Healthline they “should contact their pharmacy to discuss obtaining a replacement and ask whether they should continue taking the medication in the meantime.” The FDA says stopping a medicine unnecessarily can sometimes be more harmful than continuing it while checking recall status.

Source: Healthline News article citing FDA enforcement reports, Oct. 2, 2026.

Atlas360 reports health research and does not provide medical advice.