Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
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 3/5 (High).
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 is a Class II recall with no reported illnesses or injuries. The hazard is subpotency—tablets containing less active ingredient than labeled—which poses a risk of inadequate thyroid hormone replacement. Per the rubric, a risk-of-harm product with no reported injury is scored as High (3).
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg) in 1000-count bottles. The recall affects lot D2300191, expiring 12/31/2025, distributed nationwide to U.S. pharmacies. Levothyroxine sodium is a prescription medication used to treat thyroid hormone deficiency.
The tablets are subpotent, meaning they contain less active ingredient than the labeled 75 mcg dose. This defect was identified during manufacturing quality control. Accord Healthcare voluntarily initiated the recall on November 8, 2024, in coordination with the FDA.
Patients currently taking this medication should not stop without consulting their healthcare provider, as abruptly ceasing thyroid replacement therapy can cause health effects. Those with prescriptions filled from the affected lot should contact their pharmacy or doctor to determine if their supply is involved and to arrange appropriate alternatives. The FDA has classified this as a Class II recall.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Thyroid Medication
- Hazard
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 #: D2300191
- 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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