Telmisartan and Amlodipine recall (Viatris, Inc.)
DrugClass IIIOngoing
Summary: Viatris, Inc. is recalling Telmisartan 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.. Reason: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications.
What is being recalled
Telmisartan 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.
Why
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0049-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | October 1, 2026 |
| Reported | October 28, 2026 |
| Company | Viatris, Inc. |
| Company location | Morgantown, WV, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 21,620 30-count bottles |
More recalls from Viatris, Inc. · all drug recalls · recalls from October 2026