The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0126-2025·Announced 2024-12-18

Levothyroxine Sodium Tablets Recalled Due to Potency Failures

Viatris Inc recalls 43,765 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to potency failures where some tablets are stronger and others weaker than labeled.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall for potency failures in a critical medication where some tablets are superpotent (stronger) and others subpotent (weaker) than labeled. No illnesses or injuries have been reported in the source text. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.

Plain-English summary

Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 88 mcg, from multiple lot numbers distributed nationwide in the United States and Puerto Rico. The recalled products come in two package sizes: 90-count bottles (NDC 0378-1807-77) and 1000-count bottles (NDC 0378-1807-10). A total of 43,765 bottles have been recalled.

The recall was initiated due to potency failures in the tablets. Some tablets contain more active ingredient than labeled (superpotent), while others contain less active ingredient than labeled (subpotent). The affected lot numbers are: 8180781 (expiring Aug 2025), 3191628 (expiring Feb 2025), 3197139 (expiring Apr 2025), 3188976 (expiring Jan 2025), 3184929 (expiring Dec 2024), and 3204909 (expiring Aug 2025).

Patients should verify whether they are taking a recalled lot number by checking the label on their medication bottle. If patients have an affected lot, they should contact their healthcare provider or pharmacist for guidance regarding their medication.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Viatris Inc
Category
Drug — Thyroid Hormone
Hazard
Affected units
43,765

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 (11)

  • Lot # a) 8180781
  • Exp. Date Aug 2025
  • b)3191628
  • Exp. Date Feb 2025
  • 3197139
  • Exp. Date Apr 2025
  • 3188976
  • Exp. Date Jan 2025
  • 3184929
  • Exp. Date Dec 2024
  • 3204909

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 →

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