FDA Recalls Levothyroxine Sodium Tablets for Potency Variation
Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.
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 a risk-of-harm product (levothyroxine potency variation) where no illnesses or injuries have been reported, meeting the High severity criteria. FDA Class II classification supports this assessment.
Plain-English summary
Mylan Institutional, Inc. is recalling 690 cartons of Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg) due to potency variation. The affected lot (#3115924, expiring 06/2025) was distributed nationwide in the United States.
Some tablets in the recalled lot may be subpotent (below stated strength) or superpotent (above stated strength). This potency variation could result in patients receiving incorrect doses of the medication.
Patients taking levothyroxine from the affected lot should contact their healthcare provider or pharmacist immediately. Do not discontinue use without medical guidance. Healthcare providers can determine appropriate next steps, which may include dose verification or medication substitution.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Category
- Drug — Thyroid Hormone
- Hazard
- subpotent
- superpotent
- potency-variation
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 #: 3115924
- Exp. Date 06/2025
Distribution
Distributed nationwide across the United States.
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