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.
- Hazard
- subpotency
- therapeutic-failure
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.
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