Levothyroxine Sodium Tablets Recalled Due to Potency Failures
Viatris Inc recalls 43,765 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to potency failures where some tablets are stronger and others weaker than labeled.
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 for potency failures in a critical medication where some tablets are superpotent (stronger) and others subpotent (weaker) than labeled. No illnesses or injuries have been reported in the source text. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 88 mcg, from multiple lot numbers distributed nationwide in the United States and Puerto Rico. The recalled products come in two package sizes: 90-count bottles (NDC 0378-1807-77) and 1000-count bottles (NDC 0378-1807-10). A total of 43,765 bottles have been recalled.
The recall was initiated due to potency failures in the tablets. Some tablets contain more active ingredient than labeled (superpotent), while others contain less active ingredient than labeled (subpotent). The affected lot numbers are: 8180781 (expiring Aug 2025), 3191628 (expiring Feb 2025), 3197139 (expiring Apr 2025), 3188976 (expiring Jan 2025), 3184929 (expiring Dec 2024), and 3204909 (expiring Aug 2025).
Patients should verify whether they are taking a recalled lot number by checking the label on their medication bottle. If patients have an affected lot, they should contact their healthcare provider or pharmacist for guidance regarding their medication.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Viatris Inc
- Category
- Drug — Thyroid Hormone
- 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 (11)
- Lot # a) 8180781
- Exp. Date Aug 2025
- b)3191628
- Exp. Date Feb 2025
- 3197139
- Exp. Date Apr 2025
- 3188976
- Exp. Date Jan 2025
- 3184929
- Exp. Date Dec 2024
- 3204909
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
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27