Levothyroxine Sodium Tablets Recalled for Potency Variation and Dosage Failures
Viatris Inc. is recalling 42,331 bottles of Levothyroxine Sodium Tablets 50 mcg distributed nationwide due to potency failures resulting in both superpotent and subpotent tablets.
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 recall of a critical thyroid hormone medication with documented potency failures that could affect therapeutic efficacy. The hazard poses a risk of harm through improper thyroid hormone levels, though no illnesses have been reported.
Plain-English summary
Viatris Inc. is recalling Levothyroxine Sodium Tablets USP 50 mcg due to potency failures. The recall affects 42,331 bottles distributed nationwide in the United States and Puerto Rico.
The recalled tablets contain potency variations, with some tablets being superpotent (stronger than labeled) and others being subpotent (weaker than labeled). Levothyroxine is a thyroid hormone replacement medication used to treat hypothyroidism.
The affected lots are: 8174701 (Expiration April 2025), 8182228 (Expiration August 2025), 3193984 (Expiration March 2025), and 3206790 (Expiration August 2025). The affected package NDCs are 0378-1803-77 (90-count bottles) and 0378-1803-10 (1000-count bottles), manufactured for Mylan Pharmaceuticals Inc. in Morgantown, WV.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Category
- Drug — Thyroid Hormone
- Hazard
- potency-variation
- dosage-accuracy
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 (7)
- Lot #: a) 8174701
- Exp. Date April 2025
- 8182228
- Exp. Date Aug 2025 b)3193984
- Exp. Date Mar 2025
- 3206790
- Exp. Date Aug 2025
Distribution
Distributed nationwide across the United States.
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