The U.S. Food and Drug Administration (FDA) has issued a new update on a nationwide recall involving thousands of bottles of prescription blood pressure medication, urging consumers to check their medicine cabinets for potentially affected products.
According to a November 3 report from WCVB, the recall involves certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets manufactured by New Jersey-based Macleods Pharma USA.
The FDA classified the recall as Class II on October 26, following the company’s voluntary recall initiated on October 7. The classification means using the affected medication could cause temporary or medically reversible health consequences, although the likelihood of serious health problems is considered remote.
Which Blood Pressure Medication Bottles Are Affected?
The recall covers a total of 3,744 bottles distributed nationwide. According to the FDA’s enforcement information, the affected products include:
3,528 bottles: 30-count packages carrying lot number 12251163A and NDC 33342-246-07. 216 bottles: 90-count packages carrying lot number 12251163B and NDC 33342-246-10.Both lots have an expiration date of May 31, 2027.
Consumers who take this combination medication should check their prescription packaging for the affected lot numbers and National Drug Code (NDC).
Why Were the Pills Recalled?
The FDA identified the reason for the recall as “failed dissolution specifications.” This means the tablets did not dissolve as required during quality testing.
Dissolution testing helps determine how a medication releases its active ingredients. If a tablet does not dissolve properly, the amount of medicine available for absorption could be affected, potentially interfering with how the treatment works.
The medication combines three active ingredients: olmesartan medoxomil, amlodipine and hydrochlorothiazide. They are used together to help manage high blood pressure.
What Should Consumers Do?
People who discover that they have one of the affected bottles should contact their pharmacist or healthcare provider for guidance.
Importantly, 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.
The FDA’s Class II designation does not mean that everyone who has taken the medication will experience adverse effects. However, consumers should take the recall seriously and verify whether their prescription is included.
The recall remains an important reminder to check medication packaging and follow updates from the FDA and healthcare providers.
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