Levothyroxine Sodium tablets recalled nationwide for subpotency
Accord Healthcare is recalling 18,984 bottles of Levothyroxine Sodium 112 mcg tablets nationwide due to subpotency. The tablets contain less active ingredient than labeled, potentially reducing therapeutic effectiveness.
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: Subpotent levothyroxine is a risk-of-harm product where therapeutic failure could occur without reported injuries yet manifesting. FDA Class II classification with no reported hospitalizations indicates substantial potential harm but not acute demonstrated patient injury.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling 18,984 bottles of Levothyroxine Sodium Tablets, USP, 112 mcg due to subpotency. The product was manufactured by Intas Pharmaceuticals Limited in India and was distributed nationwide in the United States.
The affected lot is D2400725 with an expiration date of March 2026. Testing identified that these tablets contain less levothyroxine sodium than the labeled amount of 112 mcg per tablet. This means patients taking these tablets may not receive the full therapeutic benefit needed to manage their thyroid condition.
Patients currently taking Levothyroxine Sodium tablets from this lot should contact their pharmacy or healthcare provider about obtaining replacement medication. Do not stop taking levothyroxine without consulting a healthcare provider, as discontinuation could allow hypothyroidism symptoms to return.
No illnesses or injuries have been reported to date. This recall was initiated voluntarily by the manufacturer.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Thyroid Hormone
- Hazard
- subpotent
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.
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