Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals I
Summary
The FDA issued a Class III for Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, M by Viatris, Inc.. Reason: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications.
Details
Source
Drug Recall
External ID
D-0049-2027
Action Date
2026-10-28
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Quantity Affected: 21,620 30-count bottles
Reason for Recall
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-10-01
Company
Morgantown, WV
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 34 drug recalls issued in the same week, part of 76 drug-related FDA actions this month.
Viatris, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Viatris, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Viatris, Inc. have FDA actions?
Viatris, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0049-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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