FDA recalls 13,567 chlorthalidone bottles; UAE pharmacies should trace batches

The U.S. Food and Drug Administration (FDA) has listed an ongoing Class II recall of 13,567 bottles of chlorthalidone 25 mg tablets, giving UAE pharmacies and clinics a batch-check issue rather than a confirmed UAE withdrawal.

The highest-stakes readers are pharmacy operations heads, insurers and medical directors. Dubai providers should first check stock and dispensing records, then follow Dubai Health Authority (DHA) circular and recall procedures if a matching imported product is found. Abu Dhabi providers should apply Department of Health Abu Dhabi (DOH) pharmacovigilance and drug-shortage reporting routes where patient continuity is affected. Northern emirates providers should check Ministry of Health and Prevention (MOHAP) and Emirates Drug Establishment (EDE) notices before removing any medicine from sale.

What was recalled

The FDA enforcement record D-0852-2026, posted in the week ending 23 September 2026, covers Chlorthalidone Tablets USP 25 mg, 100 tablets per bottle, manufactured by Inventia Healthcare Limited in India. The affected code is batch RISA24002, NDC 64980-599-01, with expiry 04/2027. The FDA lists the recall reason as failed dissolution specifications.

An earlier FDA record, D-0610-2026, covered 11,460 bottles of the same strength. That action was initiated on 5 June 2026 and classified on 22 June 2026. It named batch RISA24001 for 100-tablet bottles and batch RISB24002 for 1,000-tablet bottles, both expiring 04/2027.

"Temporary or medically reversible adverse health consequences" may occur, according to the FDA Class II recall definition.

Why UAE operators should care

Chlorthalidone is a thiazide-like diuretic used for hypertension and fluid retention. The immediate UAE risk is operational: a patient may bring in a U.S.-dispensed bottle, an online-purchased medicine, or stock supplied through a non-routine import route. The FDA record states U.S. nationwide distribution, so UAE operators should avoid telling patients that local supply is affected unless they have verified the batch or a UAE regulator notice.

DHA pharmacy standards require recall systems that allow pharmacists to identify recalled batches, isolate stock and return recalled medicine to the supplier. DHA guidance also says all medication storage areas and clinical areas should be inspected when a recalled batch is suspected. That creates a practical obligation for Dubai clinics with in-house pharmacies, even when the initiating notice is overseas.

• Check patient-held bottles for RISA24002, RISA24001 or RISB24002.
• Ask the dispensing pharmacy for the lot number if the UAE prescription label does not show it.
• Do not advise abrupt discontinuation without prescriber review.
• Record any lack of therapeutic effect or adverse event through the applicable UAE pharmacovigilance route.

For insurers and TPAs, including Daman, Thiqa and Sukoon networks where applicable, the commercial question is replacement handling. A recalled chronic medicine can create duplicate claims, early refills and physician visits. The price impact should be checked against the specific benefit plan, pharmacy claim and registered product, rather than estimated from U.S. NDC data.

Patient advice and payer controls

Patients should contact the dispensing pharmacy with the bottle, prescription label and batch details. If the medicine was repackaged, the pharmacy should trace the original manufacturer bottle through its dispensing log. Patients should continue blood-pressure treatment until a licensed clinician gives an alternative plan, because uncontrolled hypertension carries a higher near-term risk than a routine batch query.

Clinics should create a one-page script for call centres and nurses by 2 October 2026. It should cover the three affected batch numbers, the FDA recall numbers, the instruction to speak to a pharmacist, and the escalation route for high-risk patients with heart failure, kidney disease or uncontrolled blood pressure.

Dubai providers should monitor DHA circulars and Sheryan communications. Abu Dhabi providers should monitor DOH notices and report suspected adverse reactions through DOH routes. Providers in Sharjah, Ajman, Ras Al Khaimah, Fujairah and Umm Al Quwain should check MOHAP and EDE channels. Patients looking for licensed pharmacy support can use the UAE Open Healthcare Directory to find pharmacy providers by emirate.