The Recall Desk
HighFDA (Drugs)·D-0128-2025·Announced 2024-12-18

Levothyroxine Sodium Tablets Recalled Due to Potency Failures

Viatris Inc is recalling 35,883 bottles of Levothyroxine Sodium Tablets (112 mcg) distributed nationwide due to potency failures. Some tablets contain too much active ingredient (superpotent) and others too little (subpotent). No illnesses have been reported.

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: This FDA Class II recall involves a risk-of-harm product (potency failures in thyroid hormone replacement) where no illnesses or injuries have been reported. Levothyroxine dosing requires precision to maintain proper thyroid function.

Plain-English summary

Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 112 mcg, packaged in both 90-count bottles (NDC 0378-1811-77) and 1000-count bottles (NDC 0378-1811-10). Approximately 35,883 bottles have been distributed nationwide in the United States and Puerto Rico. The recall affects five specific lots: 8171623 (90-count, expiration Feb 2025), 8164486 (90-count, expiration Nov 2024), 3205462 (1000-count, expiration Aug 2025), 3192428 (1000-count, expiration Feb 2025), and 3184096 (1000-count, expiration Nov 2024).

The recall was initiated due to potency failures discovered in the product. Some tablets in the affected lots contain more active ingredient than intended (superpotent), while others contain less (subpotent). These potency failures could affect the therapeutic effectiveness of the medication.

This recall affects patients taking Levothyroxine Sodium Tablets from the identified lot numbers and expiration dates. Levothyroxine is a commonly prescribed thyroid hormone replacement medication. Patients should verify whether their medication is from an affected lot by checking the lot number and expiration date on their prescription bottle. Consumers who believe they may have affected product should consult with their pharmacist or healthcare provider.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Viatris Inc
Category
Drug — Thyroid Hormone Replacement
Hazard
Affected units
35,883

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 (8)

  • Lot #: a) 8171623
  • Exp. Date Feb 2025
  • 8164486
  • Exp. Date Nov 2024 b)3205462
  • Exp. Date Aug 2025
  • 3192428
  • 3184096
  • Exp. Date Nov 2024

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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