FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.
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 a risk-of-harm product involving a prescription drug with confirmed out-of-specification (super-potent) formulation. Although no illnesses or injuries have been reported, the actual potency deviation creates a genuine overdose risk, supporting High severity per FDA Class II standards.
Plain-English summary
Mylan Institutional, Inc. is recalling 1,068 cartons of Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) nationwide due to out-of-specification potency. The affected medication is distributed in 100-unit dose blister cards (10 cards of 10 tablets each) per carton and was manufactured in India.
The recall was issued because testing revealed that the tablets contain higher-than-specified potency levels, making them super-potent. The affected lot is 3115773 with an expiration date of March 31, 2025 (NDC 51079-443-20).
Levothyroxine sodium is a thyroid hormone replacement medication used to treat hypothyroidism. Super-potent tablets mean patients may receive higher doses than prescribed, which could result in adverse effects from excessive thyroid hormone exposure.
Patients who believe they have received the recalled product should contact their healthcare provider or pharmacist immediately. Do not stop taking levothyroxine without medical guidance, as abrupt discontinuation could cause hypothyroid symptoms. Healthcare providers should verify whether their patients received the recalled lot and monitor them appropriately.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Affected units
- 1,068
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 3115773
- Exp. 03/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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