Macleods Pharma blood pressure pill recall spans thousands of bottles after FDA flags quality problems

Patients who take blood pressure medicine may want to review their prescription bottles to see whether they are part of a nationwide recall.

Macleods Pharma USA is recalling 3,744 bottles of a combination hypertension drug after the product did not pass federal quality testing, according to the U.S. Food and Drug Administration (FDA).

The agency said the recall was classified as Class II, meaning the affected medication could lead to temporary or medically reversible health effects.

The action covers two production lots distributed nationwide, and both are labeled with an expiration date of May 31, 2027.

Why the FDA ordered the recall

Macleods Pharma began the recall after the tablets failed dissolution specifications during quality testing.

That means the pills did not dissolve at the required rate, which could prevent the active ingredients from being released and absorbed properly.

As a result, the medicine may not reduce blood pressure as effectively as intended.

The FDA said its Class II designation indicates exposure could cause temporary or medically reversible effects, while serious outcomes are considered unlikely.

According to the FDA enforcement report, notice letters were sent to businesses and individuals who may have the affected products.

Officials also caution patients not to stop taking blood pressure medication on their own, since ending treatment could create additional health risks.

Anyone who believes they have the recalled product should check the prescription label and speak with a doctor or pharmacist.

Which medication is affected

The recall involves Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets made by New Jersey-based Macleods Pharma USA.

The drug combines three active ingredients used to treat high blood pressure.

According to Fox Business, the recall includes 3,528 bottles of 30-tablet packs and 216 bottles of 90-tablet packs.

Consumers can identify the affected products with the following details:

1. 30-count bottles: Lot number 12251163A, NDC 33342-246-07, containing 40 mg/10 mg/12.5 mg tablets.
2. 90-count bottles: Lot number 12251163B, NDC 33342-246-10, containing 40 mg/10 mg/12.5 mg tablets.

Both products expire on May 31, 2027.

The brand name Tribenzor is not part of this recall; the action applies only to the specified generic products, according to USA Today.

Other blood pressure recalls and what consumers should do

The Macleods recall comes after other regulatory actions involving blood pressure medications.

In September, India-based Inventia Healthcare recalled 13,567 bottles of 25 mg chlorthalidone tablets after they failed dissolution testing.

Chlorthalidone is used to treat high blood pressure and fluid retention.

Separately, the FDA announced a Class III recall involving 21,620 bottles of Viatris Inc.'s telmisartan and amlodipine tablets.

The 40 mg/5 mg combination may contain more telmisartan than listed.

The recall covers 30-count bottles from lots 3228113, 3228114, 3228115, 3228120, and 3228121.

Their expiration dates are listed as October 31 and November 30, according to Health and Me.