FDA orders nationwide recall of 3,744 blood pressure pill bottles

The U.S. Food and Drug Administration has removed more than 3,700 bottles of a common blood pressure medication from the market due to quality issues.

Macleods Pharma USA Inc., a company based in New Jersey, initiated the recall on October 7. The agency classified the action as a Class II recall on October 26. This classification indicates that the tablets could cause temporary or medically reversible health problems, though the risk of serious injury is considered low.

The affected product combines three active ingredients: olmesartan medoxomil, amlodipine, and hydrochlorothiazide. The pills were sold in doses of 40 mg, 10 mg, and 12.5 mg. The recall covers 3,528 bottles containing 30 pills each and 216 bottles containing 90 pills each. According to the FDA report, the drugs failed to meet dissolution specifications, meaning they did not break down or dissolve as required.

Doctors often prescribe these combinations to treat hypertension, or high blood pressure. Mayo Clinic notes that the medications are used to manage this chronic condition. The failure to dissolve properly can impact how the body absorbs the drugs.

Telemundo Chicago reached out to Macleods Pharma for comment but did not receive a response by the time the story was published. The company had distributed the bottles nationwide before ordering the pull.

Patients who have the medication in their home medicine cabinets should check their bottles for the specific lot numbers included in the recall. The FDA report details the exact quantities removed from circulation to ensure the defective supply is accounted for.