FDA Chlorthalidone Dissolution Testing Recall Affects More Than 25,000 Bottles

White blue and orange medication pill (Photo by Myriam Zilles on Unsplash )

White blue and orange medication pill (Photo by Myriam Zilles on Unsplash)

Summary
  • Inventia Healthcare recalled 25 mg chlorthalidone after dissolution testing failures
  • More than 25,000 bottles were impacted across initial and expanded recalls
  • Recalled bottles expire in April 2027 and bear three batch codes
  • FDA classified both recalls as Class II and urges patients to consult providers

The Food and Drug Administration reported that Inventia Healthcare Limited has recalled multiple lots of 25 mg chlorthalidone tablets after the product failed dissolution specifications.

FDA records show the recalled tablets were sold in 100‑ and 1,000‑tablet bottles and bear three batch codes listed by the agency.

The manufacturer issued an initial recall for a portion of the supply and later expanded the action with a secondary recall, together accounting for more than 25,000 bottles, the agency said.

The affected bottles carry an April 2027 expiration date, according to the FDA posting, and the agency has classified both recalls as Class II events.

Chlorthalidone is described by the Mayo Clinic as a diuretic that reduces water and salt in the body to lower blood pressure.

The FDA notes that a dissolution failure means tablets do not break down at the intended rate, which can affect how the active ingredient is absorbed and the medication’s effectiveness.

Implications And Guidance For Patients

The FDA advised consumers to consult their health care providers for medical guidance and to follow any instructions from the recalling company.

The agency also stated that for Class II and Class III recalls, consumers can generally continue taking the medicine unless the recalling company advises otherwise.

FDA guidance cautions that in some cases stopping a medicine may be more harmful than continuing a recalled product, and it urged patients with questions to contact their doctor or pharmacist.

The recall notice, as reported by Greta Cross at USA TODAY, includes the specific batch identifiers the FDA listed for the impacted tablet lots.

Patients who hold the affected bottles should compare their product packaging with the batch codes in the FDA notice and seek clinical advice if they have concerns about treatment effectiveness.

FDA Chlorthalidone Dissolution Testing Recall Affects More Than 25,000 Bottles | Friday Herald