Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Content
Accord Healthcare is recalling Levothyroxine Sodium Tablets 50 mcg nationwide because tablets may contain less active ingredient than labeled. Affected lot #D2300087 should be returned or discarded.
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 for subpotent drug content with no reported illnesses or injuries. The hazard is a manufacturing defect resulting in below-specification active ingredient, which is a precautionary recall without documented harm.
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg) because the active ingredient content is below the FDA-approved specification. Approximately 54,227 bottles of Lot #D2300087 (expiration date 12/31/2025) were distributed nationwide.
Patients taking this medication may not be receiving the full dose of levothyroxine needed to properly manage their thyroid condition. Levothyroxine is a critical replacement therapy for hypothyroidism and other thyroid conditions.
Consumers should contact their pharmacy or healthcare provider to determine if they have received affected medication. Patients should not stop taking their thyroid medication without medical guidance. Do not use tablets from this lot; return them to your pharmacy or discard them according to local medication disposal guidelines.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug
- Hazard
- subpotent-drug
- inadequate-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 #D2300087
- Exp Date: 12/31/2025
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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