A nationwide U.S. blood-pressure medicine recall concerns two specific lots of Macleods Pharma USA’s combination tablets. Seeing “olmesartan” in a headline does not mean every prescription containing that ingredient is affected. The manufacturer, strength and lot number are the details that matter when checking a bottle.

The product combines olmesartan medoxomil, amlodipine and hydrochlorothiazide at 40 mg/10 mg/12.5 mg. USA TODAY reported on November 2, 2026 that Macleods began the recall on October 7 and the FDA classified it as Class II on October 26. USA TODAY report. FDA recall record.

Which bottles are included?

The recall covers 3,744 bottles distributed nationwide: 3,528 bottles containing 30 tablets and 216 bottles containing 90 tablets. The recall applies to this particular strength and packaging. The identifying details are:

• 30 tablets: lot 12251163A; National Drug Code (NDC) 33342-246-07.
• 90 tablets: lot 12251163B; National Drug Code (NDC) 33342-246-10.
• Both lots expire on May 31, 2027.

The quality problem involves dissolution: the tablets did not meet specifications for releasing their ingredients. That can make treatment less effective. Taiwan’s FDA also confirmed the affected product and lots in its November 2 safety notice. Taiwan FDA notice.

What should patients do?

Start by comparing the label with the details above. If you cannot identify the manufacturer or lot, or your bottle matches, contact your pharmacist or prescriber for help checking it and arranging any necessary replacement.

Do not abruptly stop or change a prescribed medicine on your own. The FDA’s general guidance says people can usually continue Class II medicines unless the recalling company or FDA gives different instructions. It also warns that stopping a medicine can sometimes pose more risk than continuing it. FDA patient guidance.

Class II means temporary health effects are possible, while serious consequences are considered unlikely. Ask a pharmacist or doctor about your own prescription rather than changing treatment based only on a recall headline.