Levothyroxine Sodium Tablets Recalled Due to Potency Failures
Viatris Inc is recalling Levothyroxine Sodium Tablets 25 mcg nationwide due to potency failures. Some tablets are superpotent while others are subpotent, which could affect medication effectiveness.
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 potency failures in a critical prescription medication with nationwide distribution. While no illnesses or injuries have been reported in the source text, potency failures in levothyroxine pose a direct risk of harm through either subtherapeutic dosing or superpotent dosing effects.
Plain-English summary
Viatris Inc is recalling Levothyroxine Sodium Tablets USP 25 mcg due to potency failures affecting both the 90-count bottles (NDC 0378-1800-77) and 1000-count bottles (NDC 0378-1800-10). The recall involves approximately 34,845 bottles distributed nationwide within the United States and Puerto Rico. Some tablets in the affected lots are superpotent while others are subpotent, meaning the drug strength does not meet specification.
The affected lots are 8181875 (Exp. Aug 2025), 8174497 (Exp. April 2025), 3209099 (Exp. Sep 2025), 3206534 (Exp. Aug 2025), and 3196137 (Exp. April 2025). Levothyroxine is a prescription medication used for thyroid hormone replacement therapy. Potency failures could result in ineffective treatment or unintended dosing effects.
Consumers taking affected tablets should contact their healthcare provider or pharmacist to determine if their medication is from a recalled lot. Patients should not stop taking their thyroid medication without medical guidance.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Hazard
- potency-failure
- subpotent-drug
- superpotent-drug
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) 8181875
- Exp. Date Aug 2025
- 8174497
- Exp. Date April 2025 b) 3209099
- Exp. Date Sep 2025
- 3206534
- 3196137
- Exp. Date April 2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOTHYROXINE SODIUM
- HighLevothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
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- HighLevothyroxine Sodium tablets recalled for impurity specification failure
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- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
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