Attention: Those Taking Blood Pressure Medication in the U.S.! FDA Takes Action

Macleods Pharma USA, operating in the U.S. state of New Jersey, has decided to recall certain drug batches containing the active ingredients Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide, used in the treatment of high blood pressure, nationwide.

According to information released by the FDA, the recall includes 3,528 bottles of 30‑tablet packs and 216 bottles of 90‑tablet packs. In total, 3,744 bottles of medication are subject to recall.

It was reported that the drugs are distributed across the United States and recall operations are ongoing.

The drugs failed the quality test.

The reason for the recall was announced to be the drugs’ failure to meet the quality standards established in dissolution tests.

The FDA determined that the drugs did not dissolve as expected during testing. Dissolution tests are conducted to assess whether the tablets release their active ingredients within the specified conditions and time.

Failure in these tests suggests that the drug may fail to produce the expected effect, which could pose a problem. However, no information has been released indicating that the recalled products directly caused a health issue in patients.

FDA Classified It as a Second‑Class Risk Category

FDA classified the recall as “Class II.”

This category covers situations where the use of recalled products could lead to health problems that are temporary or can be corrected with medical intervention, while the likelihood of serious health issues is considered low.

People Taking Blood‑Pressure Medication Should Check Their Bottles.

According to the FDA’s announcement, the batch numbers and expiration dates of the recalled drugs were also disclosed.

The batch number for the 30‑tablet bottles was listed as 12251163A, and the National Drug Code (NDC) was given as 33342-246-07.

The batch number for the 90‑tablet bottles was announced as 12251163B, and the NDC code as 33342-246-10.

The expiration date for both products was recorded as 31 May 2027.

Officials advise people using these drugs to check the batch numbers and product codes on the bottles. It is important for patients who have drugs subject to recall to consult their doctors or pharmacists before discontinuing treatment on their own.

In September, thousands of blood‑pressure medicines were also recalled.

Recall decisions on blood‑pressure drugs in the United States have drawn attention in recent months.

In September, the India‑based Inventia Healthcare Ltd. company had also recalled 13,567 bottles of its 25‑milligram Chlorthalidone tablets due to a similar quality issue.

It had been stated that these drugs, used to treat high blood pressure and fluid accumulation in the body, also failed to meet the required standards in dissolution tests.

With the latest recall decision, inspections concerning the manufacturing quality and reliability of blood‑pressure drugs in the United States have come back into focus. It was reported that the FDA continues to monitor the recall process initiated by Macleods Pharma USA.