Macleods recalls 3,744 blood pressure bottles after pills fail quality test
Web StoryWatch this story in 15 seconds →Key takeaways
- Macleods Pharma USA voluntarily recalled 3,744 bottles of a three-in-one blood pressure pill after lab tests found the tablets did not dissolve as required.
- Only two lots are affected. They are lot 12251163A (30-count, NDC 33342-246-07) and lot 12251163B (90-count, NDC 33342-246-10).
- The FDA classed it a Class II recall on October 26, 2026. Serious harm is considered unlikely.
A blood pressure pill made by Macleods Pharma USA failed a lab test. The company is now pulling 3,744 bottles from shelves across the United States. If you take a three-in-one blood pressure pill, check your bottle today.
What happened
Macleods Pharma USA recalled two lots of its olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. The pills combine three blood pressure drugs in one tablet.
The strength is 40 mg of olmesartan. It also has 10 mg of amlodipine and 12.5 mg of hydrochlorothiazide.
The recall covers 3,528 bottles with 30 tablets each. It also covers 216 bottles with 90 tablets each. The 30-count bottles carry lot 12251163A and NDC 33342-246-07. The 90-count bottles carry lot 12251163B and NDC 33342-246-10. Both lots expire May 31, 2027.
The company started the voluntary recall on October 7, 2026. The FDA then classed the recall as Class II on October 26, 2026. The FDA recall number is D-0077-2027, according to Fox Business.
The reason the FDA gives is simple: "failed dissolution specifications." In plain words, the pills did not break down in lab tests, so they did not release their drugs fast enough. A pill must dissolve at the right rate to work.
The company notice gives one specific detail: in nine-month stability testing, the olmesartan part dissolved at a mean of 79 percent. The rule says it must not fall below 80 percent, and the other two drugs met their rules. This detail comes from the recall notice republished by the California Board of Pharmacy.
The pills were sold between November 21 and April 27. That is according to KTBS reporting cited by Nacionale. Other strengths and other lots of this drug are not in the recall.
This pill is the generic version of the brand-name drug Tribenzor. The brand-name Tribenzor is not part of this recall, according to USA Today reporting.
Why it matters
A failed dissolution test is a quality problem, not a poison problem. The tablets were not found to be dirty or mixed with a bad chemical. The worry is that the medicine may not control blood pressure as well as it should.
Blood pressure that is not controlled can raise the risk of heart trouble over time. That is why the recall matters even though no one has reported being hurt. No reports of harm have appeared in the coverage read so far, according to Nacionale.
The FDA uses Class II for this level of risk: the drug may cause harm, but that harm is usually short-lived or easy to reverse. The FDA says the chance of serious harm is remote. Class II sits between the mild Class III and the serious Class I.
This is also the third blood pressure pill recall in recent months. In October, Viatris recalled 21,620 bottles of its telmisartan and amlodipine pill over a possible excess drug level. We covered that story earlier.
In September, Inventia Healthcare recalled 13,567 bottles of chlorthalidone tablets. That drug also failed dissolution testing, Fox Business reported. These were separate recalls from separate companies.
What happens next
Check your bottle first. Look at the lot number and the NDC on the label. If your bottle shows neither lot, the recall does not touch your medicine; if it matches, call your pharmacist or doctor.
Do not simply stop taking the drug on your own, because a sudden stop can be riskier than the recall problem. The Healthy cites FDA notes: people can often keep taking a medicine in a Class II recall, but they should first check with their doctor or pharmacist. Dunlap Today's health desk gives the same simple line: keep taking the drug and call your pharmacist.
Macleods has not yet put out a press release for consumers, according to Nacionale. The recall stays open while the company pulls the lots back. Pharmacists will replace or refund the recalled bottles under normal FDA recall steps.
Heart health is on many minds this month. A separate study linked energy drinks to heart risks in young adults, and our energy drink report covers what the heart doctors found. And if your heart races after hard effort, that is usually normal, not an emergency.
This article is for information only and is not medical advice. Talk to your doctor or pharmacist about any medicine concern.
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