Levothyroxine Sodium Tablets Recalled Nationwide for Subpotent Dosing
Accord Healthcare is voluntarily recalling Levothyroxine Sodium 25 mcg tablets due to subpotency. The affected lot may contain less active ingredient than labeled, potentially impacting treatment effectiveness for patients taking this prescription thyroid medication.
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: This is an FDA Class II voluntary recall of subpotent levothyroxine tablets. Although the source reports no illnesses or injuries, a subpotent thyroid medication poses a risk of harm to patients dependent on consistent dosing for hypothyroidism management.
Plain-English summary
Accord Healthcare initiated a voluntary recall of Levothyroxine Sodium 25 mcg tablets due to subpotency—meaning the tablets contain less active ingredient than the labeled dose. Lot D2300323, with an expiration date of January 2026, is affected. The FDA classified this recall as Class II.
Approximately 4,888 bottles were distributed nationwide. Levothyroxine sodium is a prescription medication used to treat hypothyroidism and other thyroid conditions. Patients who received prescriptions filled from the affected lot may be receiving doses below the labeled strength.
No illnesses or injuries have been reported related to this recall. If you have been prescribed levothyroxine, contact your pharmacy to determine whether your medication is from the affected lot number. Your healthcare provider can verify your prescription and discuss any necessary adjustments with you.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- subpotency
- insufficient-dosage
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 # D2300323
- Exp Date: 01/2026
UPCs (12)
- 0316729447157
- 0316729449151
- 0316729452151
- 0316729454155
- 0316729453158
- 0316729448154
- 0316729451154
- 0316729457156
- 0316729450157
- 0316729456159
- 0316729458153
- 0316729455152
Distribution
Distributed nationwide across the United States.
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