The Recall Desk
HighFDA (Drugs)·D-0131-2025·Announced 2024-12-18

Levothyroxine Sodium 100 mcg Tablets Recalled for Potency Deviations Nationwide

Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.

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: FDA Class II recall involving a critical thyroid hormone medication with potency deviations that could result in improper dosing. No illnesses have been reported, but this qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.

Plain-English summary

Mylan Institutional, Inc. is recalling 2,835 cartons of Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), distributed nationwide in the United States. The recall involves Lot #3115936 with an expiration date of 07/2025 (NDC 51079-442-20). The tablets are being recalled due to potency deviations—some tablets may be subpotent (containing insufficient active ingredient) while others may be superpotent (containing excessive active ingredient). Levothyroxine sodium is a thyroid hormone replacement medication used to treat hypothyroidism, and potency variations could result in patients receiving improper doses.

This recall affects healthcare facilities, pharmacies, and patients who received Levothyroxine Sodium from Lot #3115936 with expiration date 07/2025. Any individual or facility that may have received this product should verify their supply.

Patients should contact their healthcare provider if they have Levothyroxine Sodium tablets from this lot. Healthcare providers and pharmacies should discontinue distribution and quarantine affected inventory. The FDA classified this as a Class II recall. Additional information is available through the FDA's drug recall database.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Mylan Institutional, Inc.
Category
Drug — Thyroid Hormone Replacement
Hazard
Affected units
2,835

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 #: 3115936
  • Exp. Date 07/2025

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

Same brand · LEVOTHYROXINE SODIUM

Same manufacturer · Mylan Institutional, Inc.

See all →

Same hazard · potency deviation

See all →