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.

FDA recall notice · announced October 28, 2026 · Viatris

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Quantity: 21,620 30-count bottles
Status: Ongoing
Products in this recall event:
- 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. (D-0049-2027)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.