Class IIOngoing

Levothyroxine Sodium Tablets USP recall

FDA recall D-0128-2025 · initiated Nov 18, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Superpotent Drug and Subpotent Drug: potency failures obtained

Details

Product: Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Recalling company: Viatris
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States and Puerto Rico
Initiated: Nov 18, 2024
FDA report date: Dec 18, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0128-2025 ↗

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