Viatris Recalls Telmisartan and Amlodipine Tablets Due to Superpotent Drug Risk
Viatris is recalling 21,620 bottles of Telmisartan and Amlodipine tablets because the Telmisartan content may exceed specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class III, indicating the use of the product is not likely to cause adverse health consequences. The hazard is that Telmisartan content may exceed specifications, and the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Viatris, Inc. is recalling 21,620 30-count bottles of Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg. The product is a prescription-only medication manufactured for Mylan Pharmaceuticals Inc. and made in India. The recall covers specific lots with expiration dates of October 31, 2026, and November 30, 2026.
The recall was initiated because the Telmisartan content in these lots has the potential to exceed specifications, which is classified as a superpotent drug issue. The affected product was distributed nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- TELMISARTAN AND AMLODIPINE (TELMISARTAN AND AMLODIPINE)
- Brand
- TELMISARTAN AND AMLODIPINE
- Manufacturer
- Viatris, Inc.
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot # 3228113
- 3228114
- 3228115
- Exp Date: Oct 31
- 2026
- Lot # 3228120
- 3228121
- Exp Date: Nov 30
- 2026.
UPCs (4)
- 0303781075930
- 0303781076937
- 0303781078931
- 0303781077934
Distribution
Distributed nationwide across the United States.
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