TELMISARTAN AND AMLODIPINE
Recalling Firm / Manufacturer: Viatris, Inc.
(Morgantown, WV, United States)
FDA Recall Number: D-0049-2027
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
TELMISARTAN AND AMLODIPINE
Generic Name
TELMISARTAN AND AMLODIPINE
Active Substance(s)
Telmisartan, Amlodipine Besylate
Administration Route
Oral
National Drug Code (NDC)
0378-1075
Total Quantity Recalled
21,620 30-count bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
October 28, 2026
Firm Initiation Date
October 01, 2026
FDA Classification Date
Oct 16, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0049-2027
Questo Retrieval Date: November 03, 2026 00:00 1793664008UTCC