Levothyroxine Sodium Tablets Nationwide Recall Due to Subpotency
Accord Healthcare is recalling approximately 18,984 bottles of Levothyroxine Sodium Tablets, 112 mcg, nationwide because the tablets are subpotent. Patients taking this medication should contact their pharmacy or healthcare provider immediately.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 with no reported adverse events or hospitalizations mentioned in the source text. Subpotency is a labeling/potency defect that poses a theoretical risk of therapeutic failure rather than direct patient harm, placing it in the Moderate category per the rubric.
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), distributed nationwide. The recall includes approximately 18,984 bottles from Lot # D2400725 with an expiration date of 03/2026. The manufacturer identified that the tablets are subpotent—meaning they contain less active ingredient than specified.
Levothyroxine sodium is a prescription thyroid hormone replacement medication. Subpotent tablets may not provide the intended therapeutic effect, potentially affecting patients who depend on this medication for thyroid hormone replacement therapy. The recall was initiated voluntarily by the manufacturer on April 10, 2025, and the FDA classified it as Class II on April 30, 2025.
Patients who have dispensed bottles from this lot should contact their pharmacy or healthcare provider immediately. Do not discontinue the medication without medical guidance. Healthcare providers may need to adjust treatment or verify patient dosing with alternative supplies. The affected product is manufactured by Intas Pharmaceuticals Limited in India and distributed under NDC 16729-452-15, though multiple package NDCs are affected.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- Affected units
- 18,984
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 # D2400725
- Exp Date: 03/2026
UPCs (12)
- 0316729447157
- 0316729449151
- 0316729452151
- 0316729454155
- 0316729453158
- 0316729448154
- 0316729451154
- 0316729457156
- 0316729450157
- 0316729456159
- 0316729458153
- 0316729455152
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by ACCORD HEALTHCARE, INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same brand · LEVOTHYROXINE SODIUM
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Same manufacturer · ACCORD HEALTHCARE, INC.
See all →- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
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Same hazard · subpotency
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