The United States Food and Drug Administration (FDA) has announced a nationwide recall of nearly 4,000 bottles of a commonly prescribed blood pressure medication over concerns that the drugs may not work as intended.
The recall affects a generic version of Tribenzor, a combination medication used to treat high blood pressure. According to a report by Health, the affected products may not dissolve properly, potentially reducing their effectiveness.
The medication was initially recalled on October 7, 2026, after failing to meet required dissolution specifications. On October 26, the FDA classified the recall as a Class II recall, indicating that exposure to the affected products could cause temporary or medically reversible health consequences.
MEDICATIONS AFFECTED BY THE RECALL
The recalled medication was manufactured by Macleods Pharma USA, Inc. It contains three active ingredients: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide.
The FDA identified two affected packaging sizes:
1. Thirty-tablet bottles
- National Drug Code (NDC): 33342-246-07
- Lot number: 12251163A
- Expiration date: May 31, 2027
- Number of bottles affected: 3,528
2. Ninety-tablet bottles
- National Drug Code (NDC): 33342-246-10
- Lot number: 12251163B
- Expiration date: May 31, 2027
- Number of bottles affected: 216
In total, 3,744 bottles are covered by the recall.
WHAT PATIENTS SHOULD DO
Patients who use the affected medication are advised to check their prescription bottles against the recalled lot numbers and contact their pharmacists or healthcare providers if their products are included.
Those who cannot locate the lot number on their bottles should contact their pharmacies to confirm whether their medication came from an affected batch.
Health experts have also cautioned patients against abruptly stopping their prescribed medication without medical advice.
Jennifer Young, a pharmacist and lead medication safety specialist at the Institute for Safe Medication Practices, stressed the importance of consulting healthcare professionals before making changes to medication routines.
Although medication recalls can cause concern, suddenly discontinuing blood pressure treatment could present additional health risks.
Patients are therefore encouraged to seek guidance from their healthcare providers on whether they should continue using the medication, obtain a replacement or consider an alternative treatment.
The FDA’s recall notice is intended to help patients and healthcare professionals identify the affected products and take appropriate action.
