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Class III · Lower riskActive recall

Telmisartan And Amlodipine

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameTELMISARTAN AND AMLODIPINE
Generic nameTELMISARTAN AND AMLODIPINE
Active ingredient(s)TELMISARTAN, AMLODIPINE BESYLATE
Distributed by / forMylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India
NDC0378-1075-93
Show the full FDA record
Full product labelTelmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.
Recalling firmViatris, Inc.
DistributionNationwide in the USA.
Quantity21,620 30-count bottles
Recall initiated2026-10-01
Report date2026-10-28
Recall completed—
Recall numberD-0049-2027
ClassificationClass III
FDA statusOngoing
Origin on fileMorgantown WV United States

Related

Amlodipine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.