October 2026 FDA Recall Telmisartan And Amlodipine by Viatris, Inc.
D-0049-2027 - Superpotent Drug
This Class III drug recall was voluntarily initiated by Viatris, Inc. on October 1, 2026 for the product Telmisartan And Amlodipine. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0049-2027
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
10-01-2026
10-28-2026
21,620 30-count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Viatris, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026
Lot# 3228120, 3228121, Exp Date: Nov 30, 2026.
