Quick answer
Olmesartan Recall 2026: Every Lot on the FDA List, and What to Do if Yours Matches
Four blood pressure pills that contain olmesartan are under recall in 2026, all for failing dissolution tests. Here are the NDC and lot numbers from the FDA’s own recall records, how to check your bottle, and why the FDA says not to stop on your own.
CheckedNov. 22026
The short answer
Yes. Four blood pressure pills that contain olmesartan are under recall in 2026. All four are Class II recalls, and all four are for the same reason: the tablets failed dissolution tests, meaning they didn’t dissolve the way the approved standard requires.
The newest is Macleods’ olmesartan, amlodipine and hydrochlorothiazide 40 mg/10 mg/12.5 mg: lot 12251163A (30 tablets) and lot 12251163B (90 tablets), both expiring May 31, 2027. The FDA classified it on Oct. 26.
The other three are amlodipine and olmesartan tablets distributed by Ascend Laboratories, one lot each, in the 5/40, 10/20 and 10/40 mg strengths.
If your bottle matches, don’t just stop taking it. For a Class II recall, the FDA says you can keep using the medicine unless the company or the FDA tells you otherwise. Call your pharmacist.
At a glance
- Recalled
- Olmesartan/amlodipine/hydrochlorothiazide 40/10/12.5 mg (Macleods); amlodipine/olmesartan 5/40, 10/20 and 10/40 mg (Ascend Laboratories)
- Why
- Failed dissolution specifications
- Recall class
- Class II for all four: problems that may be temporary or medically reversible, with serious harm unlikely
- How to check
- The NDC and the lot number on your bottle must both match the table below
- What to do
- Keep taking it unless told otherwise, and call your pharmacist or doctor (FDA)
- Bottles
- 37,056 in all, sold nationwide
- Press release
- None. The firms notified their customers by letter
- Last checked
- Monday, Nov. 2, 2026, against the sources at the end of this page
Check your bottle against this list
A bottle is part of a recall only if both the NDC and the lot number match. Same pill, same strength, different lot: not recalled.
| Pill and strength | NDC (bottle size) | Lot | Expires | Recalled by | FDA classified |
|---|---|---|---|---|---|
| Olmesartan, amlodipine and hydrochlorothiazide 40 mg/10 mg/12.5 mg | 33342-246-07 (30 tablets) 33342-246-10 (90 tablets) |
12251163A (30) 12251163B (90) |
May 31, 2027 | Macleods Pharma USA | Oct. 26, 2026 |
| Amlodipine and olmesartan 10 mg/40 mg | 67877-502-30 (30 tablets) | 25120696 | Dec. 31, 2026 | Ascend Laboratories (made by Alkem) | Oct. 16, 2026 |
| Amlodipine and olmesartan 10 mg/20 mg | 67877-500-30 (30 tablets) | 25121311 | March 31, 2028 | Ascend Laboratories (made by Alkem) | July 20, 2026 |
| Amlodipine and olmesartan 5 mg/40 mg | 67877-501-30 (30 tablets) | 24123460 | Oct. 31, 2027 | Ascend Laboratories (made by Alkem) | June 2, 2026 |
The NDC is the National Drug Code printed on the maker’s bottle. The lot number usually sits next to the expiration date.
If your pills came in a pharmacy bottle that doesn’t show the maker’s lot, ask the pharmacy which manufacturer and lot it filled your prescription from.
What the FDA says to do
All four are Class II. In the FDA’s definitions, that’s a product that may cause temporary or medically reversible health problems, or where serious harm is unlikely.
For Class II and III recalls, the FDA’s advice to patients is that you can continue using the medicine unless the company or the FDA directs otherwise. It adds that stopping a medicine can sometimes be more harmful than continuing to take the recalled one.
- Check the lot. Compare the lot on your label with the recall.
- Call your pharmacist or doctor if it matches or if you’re not sure.
- Returns: the FDA says companies may ask you to return recalled medicine where you bought it, and that most retailers have return and refund policies for recalled products.
For blood pressure medicine in particular, that call matters: it’s a daily pill, and a gap can be worse than the problem the recall is about.
Why these pills were recalled
Every one of the four failed a dissolution test, the lab check of how a tablet breaks down and releases its medicine.
For two of the Ascend lots, the FDA record is specific: the olmesartan part came in below specification. The Macleods record says only “failed dissolution specifications,” and the newest Ascend record says “out of specification due to dissolution.”
None of the records describe injuries, and none of the firms issued a press release. The FDA lists the first notice as a letter from each firm to its customers.
How many bottles
- 15,696 bottles of the 5/40 mg (Ascend, recall started May 5)
- 6,192 bottles of the 10/20 mg (Ascend, started July 8)
- 11,424 bottles of the 10/40 mg (Ascend, started Oct. 6)
- 3,744 bottles of the three-drug pill (Macleods, started Oct. 7): 3,528 of 30 tablets and 216 of 90
That’s 37,056 bottles in all, each distributed nationwide, according to the FDA.
One more lot, from a 2025 recall of the same Ascend 5/40 mg pill (lot 23121560), expired on April 30, 2026. If you still have it, it’s past its date anyway.
How we built this list
We searched the FDA Enforcement Report for every olmesartan product and opened each record. The table keeps only recalls the FDA lists as ongoing, with lots that haven’t expired.
The bottle total is our addition of the FDA’s own counts. We’ll recheck the FDA’s weekly report and add any new olmesartan lot.
What we don't know yet
- What pharmacies are doing for customers: none of the four firms issued consumer instructions, and the FDA lists the first notice as a letter to customers.
- Which pharmacies or states received the recalled lots: the FDA lists nationwide distribution without naming them.
- Whether more olmesartan lots will be added: the Enforcement Report is updated every week.
When any of this is confirmed, it goes into the page and the update history below.
Questions people ask
Is olmesartan being recalled?
Four products that contain olmesartan are under Class II recalls in 2026: Macleods’ olmesartan, amlodipine and hydrochlorothiazide 40/10/12.5 mg (lots 12251163A and 12251163B) and Ascend Laboratories’ amlodipine and olmesartan 5/40 mg (lot 24123460), 10/20 mg (lot 25121311) and 10/40 mg (lot 25120696). All failed dissolution tests.
What olmesartan lot numbers are recalled?
12251163A and 12251163B (olmesartan/amlodipine/hydrochlorothiazide 40/10/12.5 mg, Macleods), 25120696 (amlodipine/olmesartan 10/40 mg), 25121311 (10/20 mg) and 24123460 (5/40 mg), the last three from Ascend Laboratories. The NDC on your bottle has to match too.
Should I stop taking my blood pressure medicine if it’s recalled?
Not on your own. For Class II recalls like these, the FDA says patients can keep using the medicine unless the company or the FDA says otherwise, and that stopping can be more harmful than continuing. Call your pharmacist or doctor about a replacement.
Is Benicar recalled?
Not in 2026. No Benicar lot is among the olmesartan recalls the FDA lists as ongoing; the Benicar recalls in its Enforcement Report are older and closed. The 2026 recalls are generic combination pills from Macleods and Ascend Laboratories.
What does a Class II drug recall mean?
The FDA uses Class II for a product that may cause temporary or medically reversible health problems, or where the chance of serious harm is remote. Class I is the most serious; Class III is unlikely to cause any health problem.
Why was olmesartan recalled?
All four 2026 recalls are for failed dissolution, the lab test of how a tablet releases its medicine. For two Ascend lots, the FDA record says the olmesartan content came in below specification in that test.
