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
- potency-failure
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.
Related recalls
Same brand · LEVOTHYROXINE SODIUM
- HighLevothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
FDA (Drugs) · 2025-03-26
- HighFDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
FDA (Drugs) · 2025-03-26
- HighLevothyroxine Sodium tablets recalled for impurity specification failure
FDA (Drugs) · 2025-01-08
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
- HighFDA Recalls Levothyroxine Sodium Tablets for Potency Variation
FDA (Drugs) · 2024-12-18
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