Check Your Blood Pressure Bottle: 3,744 Bottles Recalled After Tablets Fail Dissolution Test
Direct answer: The U.S. Food and Drug Administration (FDA) classified a Class II recall of 3,744 bottles of a generic three-in-one blood pressure tablet made for Macleods Pharma USA, after the tablets failed dissolution specifications. Only two lots are affected, both expiring May 31, 2027. If your bottle matches one of those lots, contact your pharmacist or prescriber for guidance — and do not stop a prescribed blood pressure medicine on your own.
What was recalled?
The recall covers olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, 40 mg / 10 mg / 12.5 mg — a single tablet that combines three blood pressure medicines. It is a generic version of the brand-name drug Tribenzor. The FDA recall listing does not include brand-name Tribenzor.
The company, Macleods Pharma USA, voluntarily initiated the recall on October 7, 2026. The FDA classified it as Class II on October 26, 2026 (recall number D-0077-2027). A Class II recall means use of the product may cause temporary or medically reversible health consequences, or that the probability of serious harm is remote, according to the FDA definition.
The FDA reason is listed as “failed dissolution specifications.” In plain terms, the tablets did not break down and release their ingredients as required in laboratory quality testing, so they may not work as expected.
Which lots should you check?
30-tablet bottles: lot 12251163A, NDC 33342-246-07, 3,528 bottles, expires May 31, 2027. 90-tablet bottles: lot 12251163B, NDC 33342-246-10, 216 bottles, expires May 31, 2027. The recalled bottles were distributed nationwide in the United States. Check three things on your bottle: the medicine name, the manufacturer (Macleods), and the lot number.
Is my bottle affected if it looks different?
Only the two lots above are in scope. If your bottle shows a different lot number, a different manufacturer, or the brand-name product, it is not part of this recall listing. One practical catch: if your medicine was transferred into a plain pharmacy bottle, the manufacturer lot number may not appear on the label. In that case, call the pharmacy that filled the prescription and ask whether your medicine came from one of the recalled lots.
What should you do if your lot matches?
Contact your pharmacist or prescribing clinician and ask what to do next. Ask whether to keep taking the medicine while a replacement is arranged. Follow any return or disposal instructions your pharmacy provides. Do not stop a prescribed blood pressure medicine without first talking to your doctor or pharmacist — stopping suddenly can carry its own risks, and the FDA notes that patients can generally continue using a medicine in a Class II recall unless the company or the agency directs otherwise.
How is this different from other recent recalls?
Not every recall means contamination. This one is a quality failure in how the tablet dissolves, not a reported contamination finding. It is also narrow: 3,744 bottles in two lots, rather than every bottle of this medicine on the market. That is why the lot number — not just the medicine name — is the deciding detail.
Frequently asked questions
Is brand-name Tribenzor recalled? No. The FDA listing covers only the two Macleods generic lots above.
Does a Class II recall mean the medicine is dangerous? Class II is the FDA's middle severity tier. It means temporary or reversible health consequences are possible, while the probability of serious harm is remote. It is not a reason to change your routine without professional guidance.
What if I already finished a bottle from one of these lots? Talk to your pharmacist or prescriber about it, and mention any concerns about how well your blood pressure has been controlled. You can also report a medication-quality problem through the FDA MedWatch program or by calling 800-FDA-1088.
Where can I verify this myself? Search the FDA Enforcement Reports for recall number D-0077-2027, or check the lot number and NDC on your bottle against the details above.
Key Takeaway
Check the lot number, not just the medicine name: only Macleods lots 12251163A and 12251163B (3,744 bottles, expiring May 31, 2027) are recalled, and your pharmacist is the right first call if yours matches.
Sources: FDA Enforcement Report, recall D-0077-2027, classified October 26, 2026; AARP, “Blood Pressure Drug Recall: Check These Lots,” November 3, 2026; Becker's Hospital Review, November 2026, citing the FDA enforcement report.
This post was created with the help of AI tools and reviewed for accuracy against the sources cited above. It is general information only, not medical advice. For decisions about your own medicine, please talk to your doctor or pharmacist.
