Agency classClass IIOur severity:High FDA (Drugs)·D-0290-2025·Announced 2025-03-26

Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency

Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).

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: FDA Class II drug recall with out-of-specification potency identified. No reported illnesses or hospitalizations. Qualifies as a risk-of-harm product where injury has not yet been reported, per rubric Score 3 criteria.

Plain-English summary

Mylan Institutional, Inc. is recalling Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), in 100 Unit Dose Blister Cards format. The recall affects 347 cartons distributed nationwide.

The recall was initiated due to out-of-specification potency results. Testing showed the tablets contained higher potency than specified. The affected lot is 3116074, with an expiration date of September 30, 2025. The product was manufactured in India.

Patients taking this medication should contact their pharmacy or healthcare provider regarding this recall. Patients should not discontinue levothyroxine, a critical thyroid hormone, without guidance from their healthcare provider.

The recalled product

Product: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand: LEVOTHYROXINE SODIUM
Manufacturer: Mylan Institutional, Inc.
Category: Drug
Hazard: out-of-specification
super-potency
Affected units: 347

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 3116074
Exp. 09/30/2025

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 →

Same brand · LEVOTHYROXINE SODIUM

High
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Severe
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
High
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
High
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Severe
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02

Same manufacturer · Mylan Institutional, Inc.

See all →

High
FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
FDA (Drugs) · 2025-03-26
High
Levothyroxine sodium tablets recalled for potency variance
FDA (Drugs) · 2024-12-18
High
FDA Recalls Levothyroxine Sodium Tablets for Potency Variation
FDA (Drugs) · 2024-12-18
High
Levothyroxine Sodium 100 mcg Tablets Recalled for Potency Deviations Nationwide
FDA (Drugs) · 2024-12-18
High
Levothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18

Same hazard · out of specification