The Recall Desk
ModerateFDA (Drugs)·D-0395-2025·Announced 2025-05-07

Levothyroxine Sodium Tablets 50 mcg Recalled for Subpotency

Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets (50 mcg) nationwide because the tablets are subpotent and may not provide the intended therapeutic effect.

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 as stated in the source. The source text does not report any illnesses, hospitalizations, or injuries associated with this subpotency issue. Per the rubric, FDA Class II recalls typically score at 2 (Moderate) when no reported adverse health outcomes are documented and the issue is a manufacturing defect without confirmed harm.

Plain-English summary

Accord Healthcare, Inc., headquartered in Raleigh, North Carolina, is voluntarily recalling 4,872 bottles of Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg) nationwide. The recall affects Lot # D2400547 with an expiration date of 02/2026. The product is manufactured by Intas Pharmaceuticals Limited in India and distributed under NDC 16729-448-17, among other NDC numbers.

The tablets have been determined to be subpotent, meaning they contain less active ingredient than intended. Subpotent levothyroxine may fail to provide adequate therapeutic effect for patients who depend on this medication to manage thyroid conditions. Patients currently taking this medication should not stop taking their levothyroxine without consulting their healthcare provider.

Accord Healthcare initiated this recall on April 10, 2025, notifying the FDA by letter on April 30, 2025. The FDA classified this as a Class II recall. Patients with questions or concerns should contact their healthcare provider or pharmacist. Healthcare providers and distributors should cease distribution of the affected lot immediately.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
ACCORD HEALTHCARE, INC.
Category
Drug — Thyroid / Endocrine Medication
Hazard
Affected units
4,872

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 # D2400547
  • Exp Date: 02/2026

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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