FDA recall D-0136-2025

Mylan Institutional, Inc. · Class II · drug

Product

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20

Reason for recall

Subpotent and Superpotent Drug

Distribution

Nationwide in the USA.

Key facts

Status: Ongoing
Initiation date: 2024-11-19
Report date: 2024-12-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0136-2025