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

Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets nationwide due to subpotency. The tablets contain less active ingredient than labeled.

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 with no reported illnesses or injuries. Subpotent thyroid medication poses a risk to patients requiring accurate dosing, but the absence of reported harm limits the score to 3 per the rubric.

Plain-English summary

Accord Healthcare, Inc. is recalling 4,872 bottles of Levothyroxine Sodium Tablets, USP, 50 mcg, due to subpotency. The affected lot is Lot # D2400547 with an expiration date of February 2026. The product was manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide in the United States.

The tablets contain less levothyroxine sodium than the labeled amount. Levothyroxine is used to treat thyroid conditions and requires accurate dosing for effective treatment.

Patients who obtained medication from the affected lot should contact their pharmacist or healthcare provider with questions.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
ACCORD HEALTHCARE, INC.
Category
Drug
Hazard
  • subpotency

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.