Viatris Inc. is recalling 21,620 bottles of Telmisartan and Amlodipine Tablets, USP, 40 mg/5 mg, a blood pressure medication labeled for Mylan Pharmaceuticals Inc., according to the FDA enforcement record. The recall began Oct. 1, 2026, and the FDA classified it as Class III on Oct. 16, 2026. Class III is the agency's lowest risk level. No injuries or illnesses have been reported.
What's Being Recalled?
The recalled product is Telmisartan and Amlodipine Tablets, USP, 40 mg/5 mg, in 30-count bottles, Rx only, with National Drug Code 0378-1075-93. The label reads "Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV," and the product is made in India. It was distributed nationwide. Sale dates and prices were not given. The affected products and lot codes are:
- Telmisartan and Amlodipine Tablets USP 40 mg/5 mg, 30-count bottle, Lot 3228113, Expires Oct 31, 2026
- Telmisartan and Amlodipine Tablets USP 40 mg/5 mg, 30-count bottle, Lot 3228114, Expires Oct 31, 2026
- Telmisartan and Amlodipine Tablets USP 40 mg/5 mg, 30-count bottle, Lot 3228115, Expires Oct 31, 2026
- Telmisartan and Amlodipine Tablets USP 40 mg/5 mg, 30-count bottle, Lot 3228120, Expires Nov 30, 2026
- Telmisartan and Amlodipine Tablets USP 40 mg/5 mg, 30-count bottle, Lot 3228121, Expires Nov 30, 2026
Why Was This Product Recalled?
The FDA record lists the reason as "Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications." Reporting on the recall notes that the prescribing information lists low blood pressure, dizziness and rapid heartbeat as possible effects of a telmisartan overdose. The FDA defines Class III as a situation where use of the product "is not likely to cause adverse health consequences." Viatris voluntarily started the recall and notified recipients by letter.
What Should You Do?
Check the lot number and expiration date on your bottle. Three of the five lots expire Oct. 31, 2026, so they may already be at or past their dates. Do not change or stop taking a prescription blood pressure medicine without first talking to your doctor or pharmacist. The FDA's general guidance says consumers can usually keep taking medicine in Class II and III recalls unless the recalling company says otherwise. If your packaging has no lot number, a pharmacist can check whether your medication is affected. Refunds may be available at your pharmacy. For questions, you can contact the FDA at 1-888-INFO-FDA (1-888-463-6332).
Source:https://www.yahoo.com/news/us/articles/over-20-000-bottles-blood-151000170.html
