A blood pressure recall now covers 3,744 bottles of prescription combination tablets distributed nationwide, after the pills failed dissolution specifications during quality testing. The US Food and Drug Administration (FDA) classified the recall as Class II on October 26, following a voluntary recall initiated by the manufacturer on October 7. Parade reported the updated classification on November 3, 2026, citing a November 3 report from WCVB.
The blood pressure recall involves certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets made by New Jersey based Macleods Pharma USA. The three active ingredients are combined in a single tablet to help manage high blood pressure. Dissolution testing measures how a tablet releases its active ingredients. If a tablet does not dissolve as required, the amount of medicine available for absorption could be affected, and that could interfere with how the treatment works.
Class II is the FDA's middle recall category. The classification means use of the affected medication could cause temporary or medically reversible health consequences, although the likelihood of serious health problems is considered remote. It does not mean everyone who took the medication will experience adverse effects. The FDA update urges consumers to check their medicine cabinets for the affected lots.
Blood pressure recall lots and pack sizes
The blood pressure recall covers 3,744 bottles in total, according to FDA enforcement information cited by Parade. The affected products are split across two lots, both with an expiration date of May 31, 2027.
The larger lot accounts for 3,528 bottles in 30 count packages, carrying lot number 12251163A and National Drug Code (NDC) 33342-246-07. The smaller lot accounts for 216 bottles in 90 count packages, carrying lot number 12251163B and NDC 33342-246-10. Consumers who take this combination medication should check their prescription packaging for both the lot number and the NDC, since pack size alone does not identify an affected bottle.
In a blood pressure recall, prescription bottles often carry a pharmacy label over the manufacturer's label, so the lot number may be on the original container, on a pharmacy printout, or in pharmacy records. If the lot number is not visible on the bottle you hold, a pharmacist can check it against the dispensing record. Keep the bottle and any paperwork until you have confirmed whether it is part of the recall.
Why the blood pressure recall followed failed dissolution tests
Dissolution is a routine quality test for tablets. A tablet must break down and release its ingredients at a set rate so the body can absorb the intended dose. When tablets fail dissolution specifications in a blood pressure recall, the manufacturer cannot guarantee that each tablet delivers the dose printed on the label. Some tablets might release too little of an ingredient, and blood pressure control could slip. The FDA report identifies failed dissolution specifications as the reason for this blood pressure recall, without stating that any patient harm has been confirmed from these lots.
High blood pressure often has no symptoms, which makes consistent dosing important. A person taking a combination tablet for blood pressure may feel no different if a tablet releases less medicine than intended, and the problem would only show up in a blood pressure reading. That is one reason the FDA and the manufacturer ask patients to check lots promptly, rather than waiting for a routine refill to raise the question.
What patients should do next
Patients should not abruptly stop taking prescribed blood pressure medication without consulting a medical professional. Stopping treatment without an appropriate alternative could create additional health risks, including a rise in blood pressure. The correct step after finding an affected lot in this blood pressure recall is to call a pharmacist or prescriber, explain the lot number and NDC, and ask what replacement or next step they advise.
Parade's report stresses that point, and it matches standard FDA advice for prescription recalls. In this blood pressure recall, a pharmacist can usually arrange a replacement from an unaffected lot, or the prescriber can write a new prescription if no unaffected stock is available. Bring the affected bottle, or a clear photo of its lot number and NDC, to make that conversation faster.
The blood pressure recall remains a check your cabinet story rather than a stop taking your medicine story. The FDA classified it as Class II on October 26, the company began its voluntary recall on October 7, and the November 3 update brought the lot details to wider attention. Patients with lot 12251163A in a 30 count package or lot 12251163B in a 90 count package, both expiring May 31, 2027, should contact their pharmacist or health care provider for guidance.