The Recall Desk
HighFDA (Drugs)·D-0519-2025·Announced 2025-07-23

Levothyroxine Sodium Tablets Recalled for Subpotent Drug Nationwide

Accord Healthcare recalls Levothyroxine Sodium Tablets nationwide due to subpotent drug content. Affected lot #D2400679 may contain below-specification levels of active ingredient.

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 levothyroxine is a risk-of-harm product where inadequate active ingredient could affect medication efficacy, meeting High severity criteria.

Plain-English summary

Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 25 mcg in 1000-count bottles distributed nationwide. The affected lot is #D2400679 with expiration date 02/28/2026, and approximately 2,352 bottles have been distributed.

The recall is due to subpotency—testing found the drug assay to be below the approved specification. This means the tablets contain less active ingredient per dose than required.

Consumers with tablets from this lot should contact their pharmacy or healthcare provider to verify whether they received affected bottles and to discuss any necessary follow-up regarding their medication therapy.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
ACCORD HEALTHCARE, INC.
Hazard
  • subpotent-drug

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 #D2400679
  • Exp Date: 02/28/2026

UPCs (12)

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

Distribution

Distributed nationwide across the United States.