Viatris, Inc.: Telmisartan And Amlodipine, Tablets, Usp, 40mg/5 Mg, 30-count Bottle

Recall Summary Viatris is recalling Telmisartan and Amlodipine tablets (40mg/5mg) in 30-count bottles nationwide because the Telmisartan content in certain batches may be higher than the approved specification. This combination medication is used to treat high blood pressure and was distributed across all U.S. states and Washington, D.C. The recall is classified as Class III, meaning there is a potential health risk from the superpotent drug.

Recalling firm

Viatris, Inc.

Product

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

Classification

Class III

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-10-01

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide in the USA.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/3441856d-54cb-4277-aa4c-0fdea77400f0