Levothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.
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 of a prescription medication with potency errors. No illnesses or hospitalizations are reported in the source. This qualifies as High (3) per the rubric as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Mylan Institutional, Inc. is recalling 205 cartons of Levothyroxine Sodium Tablets, USP, 175 mcg (Lot #3115869, expiration date 03/2025) distributed nationwide. The affected product is supplied in 100-tablet cartons in unit-dose blister packaging (NDC 42292-040-20).
The tablets are being recalled for subpotent and superpotent drug content. Some tablets contain less active ingredient than labeled, while others contain more.
Patients who have received tablets from this lot should contact their healthcare provider. Do not stop taking levothyroxine without medical guidance. Your provider can determine if a dose adjustment is needed or if you should switch to a different lot.
Anyone with product from the affected lot should stop using it and return it to their pharmacy or contact Mylan Institutional for return instructions.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Category
- Drug — Thyroid Hormone
- Hazard
- subpotency
- superpotency
- medication-potency-error
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 #: 3115869
- Exp. Date 03/2025
Distribution
Distributed nationwide across the United States.
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