Levothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
Mylan Institutional recalls 1,133 cartons of Levothyroxine Sodium Tablets (137 mcg) nationwide. Three lots contain subpotent and superpotent tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 thyroid hormone medication. Potency variance poses a risk of incorrect dosing to patients nationwide, but no illnesses or hospitalizations are reported in the source text.
Plain-English summary
Mylan Institutional, Inc. is recalling 1,133 cartons of Levothyroxine Sodium Tablets, USP, 137 mcg (NDC 42292-041-20). The product is a prescription medication supplied as 100 tablets per carton in 10 unit-dose blister cards, manufactured for Mylan Pharmaceuticals Inc. in Morgantown, West Virginia.
The recall affects three specific lots: #3115448 (expiration 12/31/2024), #3115732 (expiration 3/31/2025), and #3116024 (expiration 9/30/2025). These lots contain subpotent and superpotent tablets, meaning the levothyroxine sodium content varies from the stated 137 mcg dose.
The recalled product was distributed nationwide in the United States.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Category
- Drug — Thyroid Medication
- Hazard
- Affected units
- 1,133
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 (6)
- Lot #: 3115448
- Exp. Date 12/31/2024
- 3115732
- Exp. Date 3/31/2025
- 3116024
- Exp. Date 9/30/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Mylan Institutional, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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