FDA recall D-0127-2025

Product

Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Distribution

Nationwide within the United States and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2024-11-18

Report date

2024-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2025