Blood pressure drug recall hits 21,620 bottles in US
Web StoryWatch this story in 15 seconds →Key takeaways
- Viatris recalled 21,620 bottles of a blood pressure drug in the United States.
- The recall covers five lot numbers of telmisartan and amlodipine tablets.
- The FDA calls it a Class III recall, its lowest risk level.
A blood pressure drug has been recalled across the United States. The recall covers 21,620 bottles of telmisartan and amlodipine tablets. The maker is Viatris Inc.
The problem is strength. Some tablets may hold more telmisartan than the label states. The US Food and Drug Administration (FDA) flagged the issue in its enforcement report.
If you take this drug, check your bottle now.
What happened
Viatris started the recall on its own on October 1, 2026. That is what a voluntary recall means. The firm acted first, and the FDA then listed the recall.
On October 16, 2026, the FDA gave the recall a Class III rating.
The drug is a mix of two medicines in one tablet. One part is telmisartan, at 40 milligrams. The other part is amlodipine, at 5 milligrams.
Doctors give this mix to people with high blood pressure. High blood pressure means the force of blood in your vessels stays too high.
The tablets come in bottles of 30. The bottles went out across the United States. The recall covers only this one product and only five lots.
A lot is one batch made at one time. Other blood pressure drugs are not part of this recall.
The FDA calls the problem a "superpotent" drug issue. That is a plain way of saying too strong. The telmisartan in some tablets may go past the set limit.
The FDA did not say how much extra telmisartan the tablets may hold. That detail is not in the public notice.
Reports say the tablets were made in India for Mylan Pharmaceuticals Inc. Mylan is based in Morgantown, West Virginia. The product code on the bottles is NDC 0378-1075-93.
That code helps drug stores find the exact product.
Which bottles are recalled
Check three things on your bottle. First, look for the drug name. It must read telmisartan and amlodipine tablets, 40 mg/5 mg.
Next, check the bottle size. It must be a 30-count bottle. Last, check the lot number near the expiry date.
These are the five recalled lots:
- Lot 3228113, expiry October 31, 2026.
- Lot 3228114, expiry October 31, 2026.
- Lot 3228115, expiry October 31, 2026.
- Lot 3228120, expiry November 30, 2026.
- Lot 3228121, expiry November 30, 2026.
If your lot number is not on this list, your bottle is not in this recall. If your drug name or dose is not the same, your bottle is not in this recall. When in doubt, ask your drug store to check for you.
Why it matters
Telmisartan and amlodipine work in two ways. Telmisartan blocks a substance in the body that makes blood vessels tighten. When vessels relax, blood pressure falls.
Amlodipine blocks calcium from entering cells in vessel walls. That also helps vessels relax and widen.
The right dose matters a lot with blood pressure drugs. Too much telmisartan can push blood pressure too low. The National Library of Medicine warns about this risk.
It lists low blood pressure as a sign of taking too much. It also lists dizziness and a rapid heart rate.
A rapid heart rate means your heart beats faster than normal. If you feel dizzy or your heart races, call your doctor at once. Do not wait for your next routine visit.
These signs need quick advice from a health worker.
At the same time, the FDA risk rating is low. Class III is the lowest level in the FDA system. The FDA has three risk levels in total.
Class III means use of the drug is not likely to cause harm. That is the FDA view, in its own words.
So the message has two sides. The dose problem is real, and you should check your bottle. But the FDA does not expect serious harm from this recall.
Both facts come from the FDA notice itself.
What to do if you take this drug
Do not stop your drug on your own. The FDA notice warns against a sudden stop. Stopping blood pressure drugs fast can cause harm too.
A sudden stop may be worse than staying on the drug for a short time.
Call your doctor or your pharmacist first. Tell them your lot number and expiry date. Ask them what to do next.
Reports say a drug store can swap a recalled bottle for a safe one. Your doctor may also switch you to a new lot.
Take your bottle with you if you visit the drug store. The staff can read the lot number for you. They can also check the product code on the label.
Keep taking your drug until your doctor or pharmacist tells you otherwise.
If you have more questions, call the FDA. The FDA number is 1-888-463-6332. You can also ask your drug store about a refund.
EatingWell reported that a return for a refund may be possible.
This recall is one of several recent drug and food recalls. A toothpaste recall covered 43 million tubes earlier. A fruit cocktail recall covered 44,000 cans at Walmart.
Recalls like these show why lot numbers matter. The lot number tells you if your item is part of the problem.
What happens next
Viatris must now pull the five lots from sale. Drug stores must check their stock for the lot numbers. Patients with a recalled bottle should get a swap or a new supply.
The FDA will keep the recall on its public list until the work is done.
No wider recall has been announced for this drug. The FDA notice names only the five lots above. If the FDA finds more lots, it will add them to the list.
News reports will follow any such update.
For now, the key step is simple. Check your bottle against the five lot numbers. Call your doctor or pharmacist if your lot matches.
Do not panic, and do not stop your drug without advice.
This article is for information only and is not medical advice. Talk to your doctor or pharmacist about your own care. They know your health history and your dose.
They can give advice that fits you.
If your heart races or you feel faint, seek care fast. You can read more about a racing heart after a nightmare and when to seek help. But a recall question is best answered by your own pharmacist.
Keep your bottle close when you call, so you can read the lot number aloud.
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