Chlorthalidone Recalled Again: 13,567 Bottles Pulled Nationwide

Inventia Healthcare's second chlorthalidone recall of 2026 pulls 13,567 bottles after tablets failed dissolution testing, bringing this year's total past 25,000 bottles.

India-based Inventia Healthcare Limited voluntarily initiated a recall of Chlorthalidone Tablets, USP, 25 mg on September 3, 2026, after the product failed dissolution specifications, according to News4JAX. The action covers approximately 13,567 bottles of 100 tablets each, distributed nationwide under NDC 64980-599-01, batch RISA24002, with an April 2027 expiration date. The FDA classified the recall as Class II on September 17, meaning any health effects would likely be temporary or medically reversible and the probability of serious harm is considered remote. This is not an isolated action: USA Today reports the company also recalled 11,460 bottles on June 5 for the same reason, bringing the combined total to more than 25,000 bottles.

The striking detail is repetition. Inventia has now recalled the same medication twice this year for the identical quality failure — a failed dissolution test — first in June and again in September, a pattern The Economic Times highlights in its coverage of the FDA's enforcement notices. Dissolution failures are subtle: as Good Housekeeping explains, the FDA defines proper dissolution as the active ingredient dissolving from its dosage form so the body can absorb it, and a tablet that breaks down at the wrong speed may simply work less effectively rather than cause obvious harm. For a blood pressure drug patients take silently for years, a quality defect that quietly undermines effectiveness is more unsettling than a dramatic contamination.

The recall documentation is specific. USA Today lists the affected batch codes as RISA24001, RISB24002 and RISA24002, with FDA recall numbers D-0610-2026 and D-0852-2026, covering 25 mg tablets in both 100- and 1,000-tablet bottles expiring April 2027. Good Housekeeping notes the September action involves more than 13,000 bottles of one lot, and advises patients who can't confirm the details on their prescription label to contact their pharmacist for help. According to News4JAX, the recall number for the September action is D-0852-2026, and healthcare providers can report adverse events through the FDA's MedWatch program at 1-800-FDA-1088.

Chlorthalidone is a diuretic, or water pill, that helps the kidneys shed excess salt and water to lower blood pressure and reduce fluid retention, according to Good Housekeeping. BlackDoctor frames the public-health stakes sharply, reporting that the American Heart Association found high blood pressure affects 62.3% of non-Hispanic Black men and 59.2% of non-Hispanic Black women, with only about 22% of Black adults with hypertension having it under control. For patients on long-term therapy, the recall covers specific batches, not every chlorthalidone prescription — and because pharmacies often dispense from larger manufacturer containers, the pharmacist is best positioned to check whether dispensed supply included a recalled batch.

The FDA's guidance, as quoted by USA Today, says consumers can generally continue taking medicine subject to a Class II recall unless the recalling company provides other instructions, warning that stopping a medication may in some cases be more harmful than continuing it. Good Housekeeping echoes the same advice: contact your healthcare provider before stopping or changing the medication, and report any illness to your doctor immediately. BlackDoctor adds practical steps — keep a record of recent blood pressure readings, report any unexpected rise, and ask your pharmacist for a verified replacement so treatment isn't interrupted while the recalled supply is swapped out.

Patients should expect pharmacists and prescribers to check dispensing records against batch RISA24002 and the earlier recalled lots, and to arrange unaffected replacement supplies. BlackDoctor's broader takeaway applies beyond this recall: check the lot with your pharmacist if you take chlorthalidone, keep following your care team's instructions until you have a replacement plan, and keep tracking your blood pressure — consistent treatment and daily habits like lower sodium and regular activity are what protect the heart, brain and kidneys over the long term.