Viatris recalls telmisartan and amlodipine tablets because telmisartan content may be too high
The tablets may contain more telmisartan than they are supposed to, so the content in these lots could go over the limit set for the product.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- Viatris, Inc.
- Hazard
- Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
- Units
- 21,620 30-count bottles
- Where sold
- Nationwide in the USA.
- FDA classification
- Class III · Ongoing
- Classified by FDA
- October 16, 2026
- Recall started
- October 1, 2026
- FDA enforcement report
- October 28, 2026
- Identifiers
- Codes: Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
- FDA recall number: D-0049-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide in the USA.
- Quantity
- 21,620 30-count bottles
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