Quick Answer
The recalled drug is olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg, made by Macleods Pharmaceuticals and sold in the U.S. by Macleods Pharma USA. It is a generic version of the brand Tribenzor.
About 3,744 bottles are affected: 3,528 bottles of 30 tablets from lot 12251163A and 216 bottles of 90 tablets from lot 12251163B. Both expire May 31, 2027.
Do not stop taking your blood pressure medicine on your own. Check your bottle, then call your pharmacist or doctor about a replacement.
Why the Olmesartan Combination Pill Was Recalled
The FDA lists the reason as "failed dissolution specifications." In plain terms, the tablets did not dissolve fast enough in lab testing, so the body might absorb the olmesartan part more slowly than it should.
The recall notice filed with the California Board of Pharmacy gives the details. During nine month stability testing, the olmesartan in the 90 count batch averaged 79 percent dissolution, just under the required 80 percent. The amlodipine and hydrochlorothiazide parts met their specifications.
Macleods said a health hazard review found no adverse event reports linked to the batch.
Recalled Lots and NDC Numbers
Look at the label on your bottle for the lot number and the National Drug Code (NDC). The recall covers:
- 30 count bottles: lot 12251163A, NDC 33342-246-07, 3,528 bottles.
- 90 count bottles: lot 12251163B, NDC 33342-246-10, 216 bottles.
- Expiration date for both: May 31, 2027.
- Strength: 40 mg olmesartan medoxomil, 10 mg amlodipine, 12.5 mg hydrochlorothiazide.
If your pharmacy repackaged the pills into its own bottle, the label may not show the maker's lot number. In that case, ask the pharmacy to check its records.
What Does Class II Mean?
Macleods started the recall on October 7, 2026, and the FDA classified it as Class II on October 26, 2026. News coverage picked it up in early November, which is why searches spiked.
A Class II recall means using the product may cause temporary or medically reversible health effects, while the chance of serious harm is remote. It is the middle of the FDA's three levels. Class I is the most serious.
This was also a retail and pharmacy level recall. That means pharmacies pull stock from shelves. It is not the kind of urgent consumer level recall where the FDA tells patients to stop using a product immediately.
What Is the Risk if I Took the Recalled Pills?
The main concern is that your blood pressure might not be controlled as well as expected. The company described the possible effect as a temporary, medically reversible drop in blood pressure control, with serious harm considered remote.
Signs your blood pressure may be running high include headaches, unusual readings on a home monitor, or readings well above your usual numbers. Most people with high blood pressure feel no symptoms at all, which is why home checks matter.
If you have chest pain, severe headache, trouble speaking, or weakness on one side, call 911. Those are emergency signs, not a recall issue.
What to Do if You Take This Blood Pressure Medicine
- Do not stop the medicine suddenly. Stopping blood pressure pills can be riskier than taking a batch that dissolves slightly slower.
- Check the lot number and NDC on your bottle against the list above.
- Call your pharmacy. If your bottle matches, ask for a replacement from a different lot.
- Talk to your doctor if you have had higher readings than usual, or if you want to switch to another medicine.
- Keep checking your blood pressure at home for a couple of weeks after switching bottles.
What Is Olmesartan, Amlodipine and Hydrochlorothiazide?
This is a three in one pill for high blood pressure. Each part works differently:
- Olmesartan medoxomil is an angiotensin II receptor blocker (ARB). It relaxes blood vessels.
- Amlodipine is a calcium channel blocker. It also widens blood vessels.
- Hydrochlorothiazide is a diuretic, or water pill. It helps the body get rid of extra salt and water.
Doctors usually prescribe the combination when one or two drugs are not enough. The brand name version is Tribenzor. This recall only covers the Macleods generic lots listed above, not Tribenzor itself or other makers' generics.
Other Recent Blood Pressure Drug Recalls
This is not the only blood pressure drug recall of 2026. Inventia Healthcare recalled certain lots of chlorthalidone tablets in June, then added another lot on September 3, which the FDA classified as Class II on September 17.
Recalls like these are fairly common for generic drugs. Most involve lab results such as dissolution or impurity limits rather than reports of harm. That does not make them unimportant, but it does put them in context.
How to Track Drug Recalls Yourself
- Search the FDA's Enforcement Report database by drug name.
- Ask your pharmacy to text or email you when a medicine you take is recalled. Most big chains offer this.
- Keep the original label or a photo of it, so you can match lot numbers quickly.
Questions to Ask Your Pharmacist
- Did my last fill come from lot 12251163A or 12251163B?
- Can you swap my supply today from a different lot or maker?
- Will a different generic look different, and is that normal?
Different generic makers often use a different pill color or shape. That alone is not a problem, but ask so you are not surprised.
FAQ
Is Tribenzor recalled?
No. The recall covers specific lots of a generic version made by Macleods, not the brand name Tribenzor.
Is plain olmesartan recalled?
This recall covers only the three drug combination tablet at 40/10/12.5 mg from the two Macleods lots listed.
Can I get a refund?
Your pharmacy will usually replace a recalled prescription at no extra cost. Ask them directly.
Should I throw the pills away?
Not until you have a replacement in hand. Your pharmacist can tell you how to return or dispose of the old bottle.
The Bottom Line
The November 2026 blood pressure medication recall covers two Macleods lots of olmesartan, amlodipine and hydrochlorothiazide tablets, 12251163A and 12251163B, because the pills dissolved slightly too slowly in testing.
Check your bottle, keep taking your medicine, and let your pharmacist swap it out. This article is general information, not medical advice, so talk to your own doctor about your treatment.
