The Recall Desk
HighFDA (Drugs)·D-0118-2025·Announced 2024-12-18

Drug Recall: Levothyroxine Sodium Tablets Affected by Potency Failures

Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.

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 recall of Levothyroxine Sodium for potency failures. The source does not document any hospitalization reports or severe adverse events. This product poses a risk of harm to patient treatment, but without hospitalization documentation, the severity is rated High rather than Severe per the rubric.

Plain-English summary

Viatris Inc is recalling Levothyroxine Sodium tablets USP, 125 mcg, manufactured by Mylan Pharmaceuticals Inc. The recalled product was distributed nationwide in the United States and Puerto Rico in two package sizes: 90-count bottles (NDC 0378-1813-77) and 1000-count bottles (NDC 0378-1813-10). A total of 92,512 bottles are affected by this recall.

The recall was initiated due to potency failures identified in the manufacturing or quality control process. Affected batches contain tablets that are either stronger than intended (superpotent) or weaker than intended (subpotent). The specific affected lots are: Lot #3182797 with expiration date November 2024, Lot #8177587, and Lot #3199816 with expiration date June 2025.

Levothyroxine Sodium is a critical medication for thyroid hormone replacement therapy. Patients in the United States and Puerto Rico who take this medication at the 125 mcg strength should check the lot number on their prescription bottles to determine if they have any of the affected batches listed above.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Viatris Inc
Category
Drug
Hazard
Affected units
92,512

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 (5)

  • Lot #: a) 3182797
  • Exp. Date Nov 2024
  • 8177587
  • b) 3199816
  • Exp. Date Jun 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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Same brand · LEVOTHYROXINE SODIUM

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Same hazard · potency failure

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