Levothyroxine sodium tablets recalled for potency failures nationwide
Viatris Inc is recalling Levothyroxine Sodium Tablets USP 150 mcg nationwide due to potency failures. Affected lots containing both subpotent and superpotent tablets expire June 2025.
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: FDA Class II recall involving a critical-dosage medication with potency failures (subpotent and superpotent tablets) that pose a risk of harm through incorrect thyroid hormone dosing. No illnesses or injuries are reported in the source material.
Plain-English summary
Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 150 mcg, distributed nationwide in the United States and Puerto Rico. The affected lots include product packaged in 90-count bottles (NDC 0378-1815-77) and 1,000-count bottles (NDC 0378-1815-10) with lot numbers 8177720 and 3200218, both with expiration dates of June 2025. A total of 9,828 bottles are affected.
The recall was initiated due to potency failures identified during manufacturing. Some tablets in the affected lots contain more active ingredient than specified (superpotent), while others contain less active ingredient than specified (subpotent).
Consumers who have taken tablets from the affected lots should consult their healthcare provider. Healthcare providers and pharmacies should identify and quarantine affected inventory from their stock.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Category
- Drug — Thyroid Replacement
- Hazard
- Affected units
- 9,828
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 (3)
- Lot #: a) 8177720
- Exp. Date Jun 2025
- b) 3200218
Distribution
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
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