Blood Pressure Pill Recalled After FDA Finds Dissolution Issues

Macleods Pharma USA Inc. pulled a widely used blood pressure medication from the market after the FDA found the pills did not dissolve properly. The company, based in New Jersey, initiated a recall on October 7 for its combination drug containing olmesartan medoxomil, amlodipine, and hydrochlorothiazide.

The agency classified the recall as Class II on October 26. This rating indicates the medication could cause temporary or medically reversible health issues, though the risk of serious injury is considered low. The primary defect was "unmet dissolution specifications," meaning the tablets failed to break down according to required standards.

The recall covers 3,744 bottles of the medication. The company withdrew 3,528 bottles containing 30 units each and 216 bottles with 90 units each. The specific dosage combination involved 40 mg, 10 mg, and 12.5 mg of the three active ingredients.

According to the Mayo Clinic, this specific combination of drugs is prescribed to treat high blood pressure. Macleods Pharma stated the recall was necessary to ensure patients received medication that met all quality requirements.

Telemundo Chicago attempted to contact Macleods Pharma for comment but had not received a response as of the publication of the report. The company continues to distribute other products while the recalled inventory is removed from the supply chain.