FDA Class II drug recall · Nationwide
Macleods Recalls 3,744 Bottles of an Olmesartan Combination Blood Pressure Pill: How to Check Your Lot
Two lots of generic olmesartan medoxomil, amlodipine and hydrochlorothiazide 40 mg/10 mg/12.5 mg tablets failed dissolution testing. The FDA classified the recall as Class II on Oct. 26, 2026.
If you take one pill a day that combines three blood pressure medicines, it is worth looking at the bottle tonight. Macleods Pharma USA, a generic drug company based in Princeton, New Jersey, has voluntarily recalled two lots of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, the generic equivalent of the brand-name drug Tribenzor. The problem, according to the FDA’s Enforcement Report, is “failed dissolution specifications.” In plain terms, laboratory testing showed the tablets were not dissolving the way they must to release their medicine on schedule.
The recall is narrow. It covers one strength, two bottle sizes and two lot numbers. That precision is good news for most of the nearly 2 million Americans who use an olmesartan product, but it also means that a quick look at a label, or a two-minute call to a pharmacy, settles the question for almost everyone. This guide walks through exactly what is recalled, what is not, and why the advice is to call before you stop taking anything.
What We Know
- Macleods Pharma USA voluntarily began the recall on Oct. 7, 2026; the FDA classified it as Class II on Oct. 26.
- The product is olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg, made by Macleods Pharmaceuticals Ltd. in Daman, India.
- Lot 12251163A covers 3,528 bottles of 30 tablets (NDC 33342-246-07); lot 12251163B covers 216 bottles of 90 tablets (NDC 33342-246-10).
- Both lots expire May 31, 2027, and were distributed nationwide.
- The FDA listed the reason as failed dissolution specifications. The recall was listed as ongoing.
What Is Still Unclear
- How far the tablets missed the dissolution standard has not been made public.
- How many bottles had already reached patients, and which pharmacies received them, is not known.
- No injuries or adverse events linked to these lots have been reported in public coverage.
- The root cause, and whether other Macleods lots were reviewed, has not been disclosed. The company could not be reached for comment by KTVU.
The Recall in Numbers: Small Batch, Big Daily Habit
A recall of 3,744 bottles sounds modest next to headline-grabbing recalls of the past, and it is. The more useful way to size it is in doses. Because this combination is usually taken once a day, every tablet represents one day of blood pressure treatment for one person. Multiply the bottles by the tablets inside, and the two lots add up to 125,280 tablets.
How the Recall Splits Between the Two Lots
That split matters for how you check. The 90-count lot is small in bottles but heavy in tablets, and 90-day supplies often come through mail-order pharmacies, where medicine may be repackaged. Either way, if your pharmacy filled your prescription from one of these bottles in the past several weeks, the lot number on the manufacturer’s bottle is the deciding detail.
Why a Pill That Will Not Dissolve Becomes a Recall
Before a tablet can lower blood pressure, it has to break apart in the digestive tract and release its active ingredients so they can be absorbed. Drugmakers prove that each batch does this consistently with a dissolution test: tablets are placed in a heated liquid that mimics conditions in the gut, and technicians measure how much drug has been released at set time points. Each approved product has its own specification, and a batch that falls outside it fails.
A failed dissolution result does not mean a tablet is toxic or contaminated. The concern is performance. If the medicine releases too slowly or unevenly, a patient might absorb less than intended, and blood pressure could drift upward without obvious symptoms. For generic drugs, dissolution consistency is also part of how manufacturers show that their product behaves like the brand-name version.
Three Medicines, Three Jobs in One Tablet
Tribenzor and its generics combine three different approaches to lowering blood pressure. Olmesartan is an angiotensin II receptor blocker, which relaxes blood vessels by blocking a hormone that tightens them. Amlodipine is a calcium channel blocker that widens arteries. Hydrochlorothiazide is a thiazide diuretic that helps the kidneys remove extra salt and water. Doctors typically prescribe the triple pill to people whose blood pressure needed more than one medicine to control, which is exactly why steady, predictable delivery of each ingredient matters.
| FDA class | Health risk definition | Typical example | Where this recall fits |
|---|---|---|---|
| Class I | Reasonable probability of serious adverse health consequences or death | Contaminated injectable, wrong drug in bottle | Not this recall |
| Class II | Temporary or medically reversible effects; serious harm remote | Tablets failing dissolution or potency tests | Macleods lots 12251163A and B |
| Class III | Unlikely to cause adverse health consequences | Labeling or packaging errors with no health effect | Not this recall |
From Factory Test to Your Medicine Cabinet: The Timeline
Dates below come from the FDA Enforcement Report as summarized by AARP, KTVU, Reader’s Digest and others, plus an earlier recall notice posted by the California State Board of Pharmacy.
- Aug 2021 to Jan 2022An earlier Macleods batch of amlodipine/olmesartan 10 mg/20 mg is distributed; it is later recalled.
- Sept 2026Inventia Healthcare recalls 13,567 bottles of chlorthalidone 25 mg for failed dissolution, another blood pressure drug.
- Oct. 7, 2026Macleods Pharma USA voluntarily starts recalling lots 12251163A and 12251163B.
- Oct. 26, 2026FDA classifies the recall as Class II and lists it in the Enforcement Report.
- Nov. 2 to 4, 2026National outlets report the recall; Macleods could not be reached for comment.
- Nov. 8, 2026The recall remains listed as ongoing; no consumer-level instructions issued by FDA.
- May 31, 2027Expiration date printed on both recalled lots.
- After May 2027Any leftover tablets from these lots should be disposed of regardless.
Not Macleods’ First Olmesartan Quality Problem
A notice posted by the California State Board of Pharmacy in March 2022 described an earlier Macleods recall of amlodipine and olmesartan medoxomil 10 mg/20 mg tablets, lot BAD62101A. That recall cited an inadequate investigation of an out-of-specification result for amlodipine content: a test measured 93.7% against a required range of 95.0% to 105.0%. It was a different product and a different defect, and it does not imply anything about the current lots beyond a pattern worth knowing.
Find Your Lot in Two Minutes: Reading the Label
The fastest check is on the manufacturer’s original bottle, where the drug name, NDC, lot number and expiration date are printed together, usually on the side label near the barcode. The table below lists every detail that identifies the recalled product.
| Label detail | Lot A | Lot B | Where to look |
|---|---|---|---|
| Drug name | Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets | Same | Front label, below the brand line |
| Strength | 40 mg/10 mg/12.5 mg | 40 mg/10 mg/12.5 mg | Directly under the drug name |
| Bottle count | 30 tablets | 90 tablets | Front or side label |
| NDC | 33342-246-07 | 33342-246-10 | Side label; 33342 identifies Macleods |
| Lot number | 12251163A | 12251163B | Printed near the expiration date |
| Expiration | 05/2027 (May 31, 2027) | 05/2027 (May 31, 2027) | Next to the lot number |
| Bottles recalled | 3,528 | 216 | Not on label; from FDA report |
| Manufacturer | Macleods Pharmaceuticals Ltd., Daman, India | Same | Small print, bottom of label |
Some pharmacy labels do list the manufacturer, often abbreviated as “MACL” or “Macleods” in small print near the drug name. If yours names a different manufacturer, you are not part of this recall. If it names Macleods and the strength is 40 mg/10 mg/12.5 mg, ask about the lot.
Affected, Unaffected or Unsure? Decode Your Situation
Use this table to match what is on your label to a next step. It covers the combinations readers most often ask about.
| What your label shows | Recalled? | Why | Next step |
|---|---|---|---|
| Macleods triple pill, 40/10/12.5 mg, lot 12251163A or B | Yes | Exact match to the FDA listing | Call pharmacist or prescriber today for a replacement |
| Macleods triple pill, same strength, different lot | No | Only two lots are listed | Keep taking as prescribed |
| Triple pill from another manufacturer | No | Recall is Macleods-specific | Keep taking as prescribed |
| Brand-name Tribenzor | No | No branded product in the notice | Keep taking as prescribed |
| Triple pill in a pharmacy vial, no lot shown | Check | Lot not visible on repackaged vials | Ask the filling pharmacy to check records |
| Plain olmesartan 5, 20 or 40 mg | No | Single-ingredient products are not listed | Keep taking as prescribed |
| Olmesartan plus amlodipine (two-drug pill) | No | Different product from the recall | Keep taking as prescribed |
| Olmesartan plus HCTZ (two-drug pill) | No | Different product from the recall | Keep taking as prescribed |
Why “Keep Taking It Until You Talk to Someone” Is the Safer Call
The instinct when you hear “recall” is to stop. With blood pressure medicine, that can backfire. The AARP report notes FDA guidance that patients can generally keep using medication from a Class II recall unless the company or the agency says otherwise, and the FDA has issued no specific consumer instruction to stop this product. Abruptly stopping a three-drug regimen removes all three effects at once, and pressure can climb within days.
Context explains the caution. According to CDC survey data for August 2021 to August 2023, 47.7% of U.S. adults have hypertension, and only about 1 in 5 of them has it under control. A tablet that dissolves imperfectly is a quality failure worth fixing quickly, but a sudden gap in treatment is a known risk for the people most likely to be on a triple pill.
Hypertension Among U.S. Adults by Age
The Control Gap: From Diagnosis to a Healthy Reading
Your Step-by-Step Response Plan
- Find the label detailsLook for the drug name, strength, manufacturer, NDC and lot number on the original bottle.
- Compare with the two recalled lotsA match requires Macleods, 40 mg/10 mg/12.5 mg, and lot 12251163A or 12251163B.
- Call the pharmacy that filled itIf the lot is not printed, ask them to check dispensing records for the lot used.
- Ask whether to continue until a swapMost pharmacists will advise continuing until a replacement from another lot or maker is in hand.
- Arrange the replacementPharmacies can usually substitute an unaffected lot or another manufacturer’s generic.
- Return or dispose as instructedFollow the pharmacy’s return instructions rather than throwing tablets in household trash.
- Track readings for 2 weeksIf you monitor at home, a short log after the switch helps spot any change.
- Report problemsSide effects or quality concerns can go to FDA MedWatch at 1-800-FDA-1088.
The Bigger Picture: A Fast-Rising Generic
Olmesartan has become one of the country’s more widely used blood pressure drugs since generic versions arrived. ClinCalc DrugStats, which draws on federal Medical Expenditure Panel Survey data, estimates 7,175,746 olmesartan prescriptions for 1,957,158 U.S. patients in 2023, ranking it the 96th most prescribed drug. Those totals cover all olmesartan products, not only the triple combination that was recalled.
Olmesartan’s Climb Up the U.S. Prescription Rankings
The recall also lands during a busy stretch for blood pressure drug quality. In September, Inventia Healthcare recalled 13,567 bottles of chlorthalidone 25 mg tablets, also for failing dissolution testing. Neither recall is connected to the nitrosamine impurities that drove the wide recalls of valsartan, losartan and irbesartan in 2018 and 2019; dissolution failures concern how a tablet performs, not what contaminates it.
Habits That Make the Next Recall Easier
- Photograph each new bottleCapture the lot and expiration in under 10 seconds at pickup.
- Ask for the maker’s nameRequest that the manufacturer appear on your vial label.
- Use one pharmacyA single record makes a lot lookup take minutes, not days.
- Keep 7 days in reserveA small buffer prevents gaps while a replacement is arranged.
- Check FDA listings monthlyThe Enforcement Report is updated weekly and searchable by drug name.
- Log readings twice a weekTwo home checks a week make changes easier to spot.
Frequently Asked Questions
Which olmesartan medication was recalled in 2026?
Macleods Pharma USA recalled olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, 40 mg/10 mg/12.5 mg, lots 12251163A (30-count, NDC 33342-246-07) and 12251163B (90-count, NDC 33342-246-10), both expiring May 31, 2027. The recall began Oct. 7, 2026, and the FDA classified it as Class II on Oct. 26.
Why was the olmesartan combination pill recalled?
The FDA listed “failed dissolution specifications.” Testing found the tablets did not dissolve and release their medicine as required. The recall is not related to contamination or nitrosamine impurities.
Is plain olmesartan or brand-name Tribenzor recalled?
No. The notice covers only the Macleods triple-combination generic at one strength and two lots. Single-ingredient olmesartan, two-drug olmesartan combinations, other manufacturers’ generics and Tribenzor are not part of this recall.
Should I stop taking my blood pressure medicine if it was recalled?
Not on your own. FDA guidance generally allows patients to keep using medicine from a Class II recall unless told otherwise, and stopping blood pressure medication suddenly can be risky. Contact your pharmacist or prescriber, who can arrange a replacement and tell you whether to continue until it arrives.
How do I find the lot number on my prescription?
Check the manufacturer’s original bottle, where the lot number appears near the expiration date. If your pills came in a pharmacy vial without a lot number, call the pharmacy that filled it and ask them to check their dispensing records.
What does a Class II drug recall mean?
The FDA uses Class II when a product may cause temporary or medically reversible health effects and the chance of serious harm is remote. It is less severe than Class I and more serious than Class III.
Can I get a replacement or refund for recalled olmesartan?
Pharmacies typically replace recalled medicine with an unaffected lot or another manufacturer’s equivalent. No specific refund program has been announced for this recall, so ask your pharmacy how it is handling returns and replacements.
How do I report a problem with my blood pressure medication?
You can report side effects or quality concerns to the FDA’s MedWatch program online or by calling 1-800-FDA-1088. It also helps to tell your doctor and pharmacist, especially if your home blood pressure readings have changed.
The Short Version
Macleods Pharma USA is recalling 3,744 bottles of generic olmesartan medoxomil, amlodipine and hydrochlorothiazide 40 mg/10 mg/12.5 mg tablets, lots 12251163A and 12251163B, after the tablets failed dissolution testing. The FDA rated it Class II, meaning serious harm is considered remote. Plain olmesartan, Tribenzor and other makers’ versions are not affected. Check the lot on the original bottle or ask the pharmacy that filled your prescription, keep taking your medicine until a professional tells you otherwise, and get a replacement from an unaffected lot.
Omisha is a health writer passionate about turning complex medical research into clear, actionable content readers can trust. She covers everything from nutrition and mental wellness to chronic disease management, always grounding her work in credible science and real-world relevance. When she's not writing, she's usually reading up on the latest health studies or exploring new wellness trends to write about next.
