FDA recall D-0131-2025

Product

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 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: 51079-442-20

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-0131-2025