PlainRecalls
FDA Drug Moderate Class II Ongoing

Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reported: December 18, 2024 Initiated: November 18, 2024 #D-0125-2025

Product Description

Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reason for Recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Details

Recalling Firm
Viatris Inc
Units Affected
63,077 bottles
Distribution
Nationwide within the United States and Puerto Rico
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.. Recalled by Viatris Inc. Units affected: 63,077 bottles.
Why was this product recalled?
Superpotent Drug and Subpotent Drug: potency failures obtained
Which agency issued this recall?
This recall was issued by the FDA Drug on December 18, 2024. Severity: Moderate. Recall number: D-0125-2025.