Levothyroxine Sodium tablets recalled for subpotent assay across multiple lots
Accord Healthcare is recalling Levothyroxine Sodium tablets due to assay results below approved specifications. The recalled product is a thyroid replacement medication distributed nationwide.
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: FDA Class II recall for manufacturing defect (assay below specification) with no reported illnesses or injuries. Subpotent thyroid medication poses risk of inadequate therapeutic effect but no patient harm reported, placing this at High severity per rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 100 micrograms (0.1 mg), due to assay results that fall below approved specifications. The recall affects 9,739 bottles distributed nationwide in the United States.
Two lots are affected: Lot #D2300092 (expiration 12/31/2025) and Lot #D2400722 (expiration 03/31/2026). The tablets are manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare, Inc., based in Raleigh, North Carolina.
Levothyroxine Sodium is a prescription medication used to treat hypothyroidism. When a drug is subpotent—meaning it contains less active ingredient than specified—patients may not receive the full therapeutic effect intended. The FDA classified this as a Class II recall.
Consumers who have these affected lots should contact their healthcare provider or pharmacist. Do not discontinue thyroid medication without medical guidance, as this could result in inadequate thyroid hormone replacement. Return the product to the pharmacy or contact Accord Healthcare for further instructions.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Thyroid replacement
- Hazard
- subpotent-drug
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 (4)
- Lot #D2300092
- Exp Date: 12/31/2025
- Lot #D2400722
- Exp Date: 03/31/2026
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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