Levothyroxine sodium tablets recalled for potency variance
Mylan Institutional is recalling 1,664 cartons of levothyroxine sodium tablets nationwide due to potency variance. The tablets contain subpotent and superpotent units, affecting the consistency of each dose.
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 a prescription medication with documented potency variance. While no illnesses or injuries are reported, potency variance in levothyroxine represents a risk-of-harm situation where therapeutic efficacy and safety are directly affected by dosage inconsistency. Per rubric, theoretical hazards without reported incidents score at most 3.
Plain-English summary
Mylan Institutional, Inc. is recalling Levothyroxine Sodium Tablets, USP, 125 mcg. The recall involves 1,664 cartons with Lot #3115893 (expiration date 6/2025).
The tablets contain subpotent and superpotent units—some tablets contain less than the labeled 125 mcg dose, while others contain more than the labeled dose. This potency variance affects the consistency and reliability of each tablet's active ingredient content.
The recalled product was distributed nationwide in the United States.
Patients who have tablets from the affected lot should contact their healthcare provider or pharmacist for guidance on their medication. Do not discontinue use without medical advice.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Category
- Drug
- Hazard
- potency-variance
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 (2)
- Lot #: 3115893
- Exp. Date 6/2025
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
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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
- HighFDA Recalls Levothyroxine Sodium Tablets for Potency Variation
FDA (Drugs) · 2024-12-18
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