Levothyroxine sodium tablets recalled for potency failures nationwide
Viatris Inc is recalling Levothyroxine Sodium Tablets USP 150 mcg nationwide due to potency failures. Affected lots containing both subpotent and superpotent tablets expire June 2025.
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 involving a critical-dosage medication with potency failures (subpotent and superpotent tablets) that pose a risk of harm through incorrect thyroid hormone dosing. No illnesses or injuries are reported in the source material.
Plain-English summary
Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 150 mcg, distributed nationwide in the United States and Puerto Rico. The affected lots include product packaged in 90-count bottles (NDC 0378-1815-77) and 1,000-count bottles (NDC 0378-1815-10) with lot numbers 8177720 and 3200218, both with expiration dates of June 2025. A total of 9,828 bottles are affected.
The recall was initiated due to potency failures identified during manufacturing. Some tablets in the affected lots contain more active ingredient than specified (superpotent), while others contain less active ingredient than specified (subpotent).
Consumers who have taken tablets from the affected lots should consult their healthcare provider. Healthcare providers and pharmacies should identify and quarantine affected inventory from their stock.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Category
- Drug — Thyroid Replacement
- 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 (3)
- Lot #: a) 8177720
- Exp. Date Jun 2025
- b) 3200218
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOTHYROXINE SODIUM
- HighFDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
FDA (Drugs) · 2025-03-26
- HighLevothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
FDA (Drugs) · 2025-03-26
- HighLevothyroxine Sodium tablets recalled for impurity specification failure
FDA (Drugs) · 2025-01-08
- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- SevereMG217 Multi-Symptom Treatment Cream recalled for microbial contamination
FDA (Drugs) · 2026-05-27