Levothyroxine sodium tablets recalled for potency failures nationwide
Viatris Inc is recalling Levothyroxine Sodium 100 mcg tablets for potency failures causing some tablets to be too strong and others too weak. Approximately 65,169 units are affected nationwide.
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 is an FDA Class II drug recall involving potency defects in levothyroxine, a critical thyroid medication. Although no illnesses or injuries have been reported, the risk of harm is real: subpotent tablets may result in therapeutic failure, while superpotent tablets may cause overdose effects. This meets the rubric criterion for Score 3 (High): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 100 mcg, manufactured for Mylan Pharmaceuticals Inc, due to potency failures. Some tablets in affected lots contain higher-than-labeled amounts of active ingredient (superpotent), while others contain lower-than-labeled amounts (subpotent). The recall affects 65,169 units distributed nationwide within the United States and Puerto Rico.
The affected lots include specific lot numbers and expiration dates. In 90-count bottles: Lot 8171269 (February 2025 expiration) and Lot 8179579 (July 2025 expiration). In 1000-count bottles: Lots 3183815, 3189147, 3192027, 3202894, 3192026, 3199781, 3192028, and 3202895, with expiration dates ranging from November 2024 to July 2025.
Subpotent tablets may not provide therapeutic benefit for patients with thyroid conditions, potentially causing treatment failure. Superpotent tablets may result in overdose-related adverse effects such as increased heart rate and tremors. Patients should contact their healthcare provider or pharmacist if they have questions about their current levothyroxine supply and should not stop taking their medication without consulting their physician.
Healthcare providers and patients with affected lot numbers should verify their current supply and contact their pharmacy if they believe they have received recalled tablets.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Category
- Drug — Thyroid Medication
- Hazard
- potency-failure
- incorrect-strength
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 (15)
- Lot #: a) 8171269
- Exp. Date Feb 2025
- 8179579
- Exp. Date July 2025 b)3183815
- Exp. Date Nov 2024
- 3189147
- Exp. Date Jan 2025
- 3192027
- 3202894
- Exp. Date Jul 2025
- 3192026
- 3199781
- Exp. Date Jun 2025. 3192028
- exp. date Feb 2025 3202895
- exp. date July 2025
Distribution
Distributed nationwide across the United States.
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