Levothyroxine Sodium Tablets Recalled for Subpotency Issue Nationwide
Accord Healthcare is recalling 54,432 bottles of Levothyroxine Sodium Tablets 88 mcg due to subpotency—tablets contain less active ingredient than specified. Lot D2300045 was distributed nationwide; patients should verify their lot number and contact their pharmacy.
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 FDA Class II recall involves no reported illnesses or injuries, falling under the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' which scores a maximum of 3 (High). Subpotency in a prescription thyroid medication poses risk of inadequate treatment in patients dependent on precise dosing.
Plain-English summary
Accord Healthcare, Inc. is recalling 54,432 bottles of Levothyroxine Sodium Tablets, 88 mcg (0.088 mg), due to subpotency. During long-term stability testing, the company discovered that tablets contain less active ingredient than the approved specification range.
The affected product is lot number D2300045 with an expiration date of 12/31/2025. This lot was distributed nationwide in the United States. The medication is manufactured by Intas Pharmaceuticals Limited in Dehradun, India for Accord Healthcare, Inc. in Raleigh, North Carolina.
Patients taking this medication should check their bottle for lot number D2300045. Those with the affected lot should contact their pharmacy or physician for guidance.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- subpotency
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 # D2300045
- Exp 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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