Blood pressure drug recall: FDA flags thousands of bottles after pills fail quality tests; here's what to check

A nationwide recall of thousands of prescription blood pressure medication bottles has prompted patients to examine their bottle numbers as well as other important details.

The recall is related to a combination medication which is prescribed for managing hypertension. The US Food and Drug Administration (FDA) cited a manufacturing quality problem that might affect the dissolving process of the pills after taking them.

Which blood pressure medication is being recalled?

Macleods Pharma USA had announced a voluntary recall of the product on October 7th, while the FDA classified it on October 26th. The said drug is constituted of three medicines that are used for treating hypertension, and these include olmesartan medoxomil, amlodipine and hydrochlorothiazide.

The recall involves 3,528 bottles of 30 tablets each and 216 bottles of 90 tablets each, making a total of 3,744 bottles. Both lots have an expiry date of May 31, 2027.

Patients can identify the recalled medication using the following details:

• 30-tablet bottles: Lot 12251163A; NDC 33342-246-07.
• 90-tablet bottles: Lot 12251163B; NDC 33342-246-10.

The FDA placed the recall into Class II category on October 26. According to the classification, a Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.

Why were the tablets recalled?

"Failed dissolution specifications" was stated as the reason for the recall as cited by the FDA. A failed dissolution test refers to the medicine lacking in releasing its ingredients into the body as intended.

Failing in doing so might not release the active ingredients in accordance with a patient's needs. This can potentially affect how much of the drug becomes available for the body to absorb.

Patients who find a matching lot number should contact their pharmacist or healthcare provider to discuss the recall and obtain guidance on a replacement. They should not stop taking prescribed blood pressure medication without medical advice, as uncontrolled hypertension can carry serious health risks.