Levothyroxine 88 microgram tablets recalled as subpotent after long term stability testing
Accord Healthcare is recalling 54,432 bottles of Levothyroxine Sodium Tablets USP 88 mcg after long-term stability testing found assay content below the approved specification range.
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: Scored 3 under the risk-of-harm criterion: subpotency means patients receive less of a daily hormone than prescribed, and no injuries are reported.
Plain-English summary
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 tablets per bottle, manufactured for Accord Healthcare of Raleigh, North Carolina by Intas Pharmaceuticals Limited of Dehradun, India, are being recalled as subpotent.
During long-term stability testing of the 88 mcg strength, the assay content was observed below the approved specification range, meaning the tablets contain less active ingredient than the label states.
The recall covers 54,432 bottles from lot D2300045, expiring 31 December 2025. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Levothyroxine is a prescription thyroid hormone taken daily, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Thyroid hormone
- Affected units
- 54,432
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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