The Recall Desk
HighFDA (Drugs)·D-0125-2025·Announced 2024-12-18

Levothyroxine sodium tablets recalled for potency failures nationwide

Viatris Inc is recalling Levothyroxine Sodium Tablets USP 75 mcg due to potency failures affecting approximately 63,077 bottles distributed nationwide in the US and Puerto Rico. Some tablets are superpotent while others are subpotent.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall for confirmed potency failures in a critical thyroid medication where improper dosing (either excessive or insufficient) presents risk of harm to patients. No illnesses or injuries have been reported.

Plain-English summary

Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 75 mcg, in 90-count and 1000-count bottles manufactured for Mylan Pharmaceuticals Inc. The recall affects approximately 63,077 bottles.

The recall was initiated due to confirmed potency failures. Some tablets are superpotent (containing more active ingredient than the labeled 75 mcg dose), while others are subpotent (containing less). Precise dosing of levothyroxine is critical for patients relying on thyroid hormone replacement therapy.

The affected products were distributed nationwide throughout the United States and Puerto Rico. Eight lot numbers with expiration dates between December 2024 and September 2025 are included in the recall.

Patients who have affected bottles should contact their healthcare provider or pharmacist immediately to determine whether their medication is included in the recall and to discuss appropriate next steps.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Viatris Inc
Category
Drug
Hazard
Affected units
63,077

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Lot #: a) 8177078
  • Exp. Date May 2025
  • 8168596
  • Exp. Date Jan 2025 b) 3199313
  • 3194118
  • Exp. Date Mar 2025
  • 3186238
  • Exp. Date Dec 2024
  • 3209590
  • Exp. Date Sep 2025
  • 3199317
  • 3188733
  • Exp. Date Jan 2025

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Viatris Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same brand · LEVOTHYROXINE SODIUM

Same manufacturer · Viatris Inc

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Same hazard · potency failure

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