The Recall Desk
ModerateFDA (Drugs)·D-0397-2025·Announced 2025-05-07

Levothyroxine Sodium Tablets Nationwide Recall Due to Subpotency

Accord Healthcare is recalling approximately 18,984 bottles of Levothyroxine Sodium Tablets, 112 mcg, nationwide because the tablets are subpotent. Patients taking this medication should contact their pharmacy or healthcare provider immediately.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported adverse events or hospitalizations mentioned in the source text. Subpotency is a labeling/potency defect that poses a theoretical risk of therapeutic failure rather than direct patient harm, placing it in the Moderate category per the rubric.

Plain-English summary

Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), distributed nationwide. The recall includes approximately 18,984 bottles from Lot # D2400725 with an expiration date of 03/2026. The manufacturer identified that the tablets are subpotent—meaning they contain less active ingredient than specified.

Levothyroxine sodium is a prescription thyroid hormone replacement medication. Subpotent tablets may not provide the intended therapeutic effect, potentially affecting patients who depend on this medication for thyroid hormone replacement therapy. The recall was initiated voluntarily by the manufacturer on April 10, 2025, and the FDA classified it as Class II on April 30, 2025.

Patients who have dispensed bottles from this lot should contact their pharmacy or healthcare provider immediately. Do not discontinue the medication without medical guidance. Healthcare providers may need to adjust treatment or verify patient dosing with alternative supplies. The affected product is manufactured by Intas Pharmaceuticals Limited in India and distributed under NDC 16729-452-15, though multiple package NDCs are affected.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
ACCORD HEALTHCARE, INC.
Category
Drug — Thyroid Hormone Replacement / Prescription
Hazard
Affected units
18,984

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 # D2400725
  • Exp Date: 03/2026

UPCs (12)

  • 0316729447157
  • 0316729449151
  • 0316729452151
  • 0316729454155
  • 0316729453158
  • 0316729448154
  • 0316729451154
  • 0316729457156
  • 0316729450157
  • 0316729456159
  • 0316729458153
  • 0316729455152

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by ACCORD HEALTHCARE, 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 4 products in this recall →

Related recalls

Same brand · LEVOTHYROXINE SODIUM

Same manufacturer · ACCORD HEALTHCARE, INC.

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Same hazard · subpotency

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