The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0119-2025·Announced 2024-12-18

Levothyroxine Sodium Tablets Recalled Due to Potency Failures

Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 137 mcg due to potency failures in some tablets being stronger or weaker than specified. The recall affects 118,324 bottles distributed nationwide in the United States and Puerto Rico.

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 with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 137 mcg in both 90-count and 1000-count bottles. The affected products span six lot numbers with expiration dates ranging from December 2024 to September 2025. A total of 118,324 bottles have been distributed nationwide within the United States and Puerto Rico.

The recall was initiated due to potency failures identified in the tablets. Testing confirmed that some tablets are superpotent (containing higher-than-specified potency) while others are subpotent (containing lower-than-specified potency). This variability in drug strength could affect the consistent treatment of thyroid conditions for patients who depend on precise dosing.

Patients taking Levothyroxine Sodium Tablets from the affected lot numbers should contact their healthcare provider or pharmacy immediately. Consumers should not stop taking their medication without medical guidance, as abruptly discontinuing levothyroxine can be harmful. Healthcare providers can advise patients on whether to continue using their current supply or switch to an alternative source of levothyroxine.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Viatris Inc
Category
Drug — Thyroid Medication
Hazard
Affected units
118,324

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 (10)

  • Lot #: a) 8165919
  • Exp. Date Dec 2024
  • 8172050
  • Exp. Date Mar 2025
  • 8183251
  • Exp. Date Sept 2025 b) 3185542
  • Exp. date Dec 2024
  • 3192838
  • 3208172
  • Exp. Date Sept 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 →

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