D-0049-2027 Class III Ongoing
FDA drug recall D-0049-2027 was initiated by Viatris, Inc. on Oct 1, 2026 and is designated Class III. Reason for recall: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications The recall status is ongoing. Affected quantity: 21,620 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 28, 2026
- Initiation Date
- Oct 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,620 30-count bottles
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.
Reason for Recall
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0049-2027
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026