Levothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Tablets
Mylan Institutional recalls levothyroxine sodium tablets (lot 3115707) due to subpotent and superpotent tablets. The product was distributed nationwide. Consult your healthcare provider.
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 confirmed potency defects (subpotent and superpotent tablets). No illnesses or injuries have been reported in the source material, but dosage accuracy is critical for thyroid hormone replacement therapy.
Plain-English summary
Mylan Institutional, Inc. is recalling Levothyroxine Sodium Tablets, USP, 112 mcg due to subpotent and superpotent tablets. Some tablets contain less active ingredient than labeled while others contain more than labeled.
The affected product is lot number 3115707 expiring 02/2025. A total of 988 cartons were distributed nationwide in the USA. Each carton contains 10 unit dose blister cards of 10 tablets each.
Levothyroxine sodium is a thyroid hormone replacement medication. Incorrect potency could affect thyroid hormone levels and treatment effectiveness. Patients taking this medication should not stop without consulting their healthcare provider. If you have received this product, contact your pharmacy or healthcare provider for guidance.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- subpotent
- superpotent
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 #: 3115707
- Exp. Date 02/2025
Distribution
Distributed nationwide across the United States.
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