FDA Drugs recall ·
Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle… recall
- Recall number
- D-0049-2027
- Date
- (initiated October 1, 2026)
- Company / brand
- Viatris Inc
3711 Collins Ferry Rd, Morgantown, WV, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 21,620 30-count bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Distribution
Nationwide in the USA.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0049-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.