Levothyroxine Sodium Tablets recalled nationwide for potency failures
Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.
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 for potency failures in a critical thyroid medication. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High classification.
Plain-English summary
Viatris Inc. is recalling Levothyroxine Sodium Tablets USP, 175 micrograms, distributed nationwide in the United States and Puerto Rico. The recall affects approximately 19,549 bottles in two package sizes: 90-count bottles (NDC 0378-1817-77) and 1000-count bottles (NDC 0378-1817-10).
The recall was initiated due to potency failures identified in certain batches. Some tablets contain higher-than-specified amounts of active ingredient (superpotent), while others contain lower-than-specified amounts (subpotent). Affected lots include 3192915 and 8172108 (with March 2025 expiration dates) for 90-count bottles, and lot 3208680 (with September 2025 expiration date) for 1000-count bottles.
Patients currently taking levothyroxine should check their prescription against the affected lot numbers and expiration dates listed above. Those with recalled medication should contact their pharmacist or healthcare provider for guidance on potential replacement or next steps.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Hazard
- potency-failure
- over-dosing-risk
- under-dosing-risk
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) 3192915
- 8172108
- Exp. Date Mar 2025
- b) 3208680
- Exp. Date Sep 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
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- 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
- HighLevothyroxine Sodium 100 mcg Tablets Recalled for Potency Deviations Nationwide
FDA (Drugs) · 2024-12-18
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