FDA recall D-0290-2025

Mylan Institutional, Inc. · Class II · drug

Product

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

Reason for recall

Super-Potent Drug: Out of specification potency results were obtained.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-03-07
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2025