FDA Classifies Recall of 3,744 Bottles of Combination Blood Pressure Drug as Class II After Dissolution Test Failure
The U.S. Food and Drug Administration has classified a recall involving a combination blood pressure medication made by Macleods Pharma USA as Class II. The affected product is Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, which contains three blood-pressure-lowering ingredients. FDA records say the tablets failed dissolution specifications, meaning they did not dissolve as required during quality testing. The recall covers 3,744 bottles distributed nationwide. Patients should check the lot number and National Drug Code (NDC) on their prescription bottles and contact a pharmacist or prescriber to confirm what to do next.
The FDA Enforcement Report lists a voluntary recall initiated by Macleods Pharma USA. It covers two bottle sizes:
Both lots have an expiration date of May 31, 2027, and the product strength is 40 mg/10 mg/12.5 mg. The FDA classified the action as Class II. That category means use of the affected product may cause temporary or medically reversible adverse health consequences, while the likelihood of serious consequences is considered remote. The classification does not mean that every person who took the medication will experience an adverse effect.
Dissolution testing measures how a tablet releases its active ingredients under specified conditions. A tablet that does not meet the required dissolution specifications has not released its ingredients at the rate or extent required by quality standards. That could affect how the medicine is released and absorbed in the body. The FDA's stated reason for the recall is “Failed Dissolution Specifications.” Publicly available information does not identify which ingredient or manufacturing step caused the failure, and it does not report confirmed patient injuries resulting from the affected lots.
The product is a generic combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide. Some media describe it as a generic version of Tribenzor. The recall notice identifies specific Macleods-manufactured generic lots; it should not be interpreted as a recall of every product containing the same ingredients or of all brand-name products.
Macleods initiated the voluntary recall on October 7, 2026. The FDA added it to its Enforcement Report and classified it as Class II on October 26. In early November, multiple news organizations published reminders for consumers to check their prescription bottles. The FDA's official record is the primary reference for the affected product, lot numbers and recall classification. News coverage can help explain the scope, but it does not replace the FDA record or advice from a pharmacist who can review an individual prescription.
Patients can compare the product name, NDC and lot number on their prescription bottle with the information above. If all details match, they should contact the dispensing pharmacy or prescribing clinician to discuss an alternative and next steps. Prevention, citing FDA information, reported that the FDA's public recall record did not provide specific consumer instructions to stop taking the medication. Patients should not abruptly discontinue prescribed blood pressure medicine on their own. They should first discuss the recall with a doctor or pharmacist to avoid an interruption in blood pressure treatment.
If the information on a bottle does not match, patients should not assume that it is included simply because the ingredients are the same. The recall is limited to the specified manufacturer, strength, lots and NDCs. Patients or caregivers with questions can take the bottle to a pharmacy for verification and monitor the FDA's recall information for updates.