Levothyroxine Sodium Tablets Recalled Due to Below-Specification Potency
Accord Healthcare is recalling Levothyroxine Sodium Tablets (112 mcg) due to subpotency; the drug's active ingredient levels fell below FDA specifications. Affected patients should consult their doctors.
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 is an FDA Class II recall with no reported illnesses or injuries. However, subpotent medication represents a risk of harm, as the tablets would not deliver the intended active ingredient dose. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 112 micrograms (mcg), supplied in 1000-count bottles, due to subpotency. The FDA determined that the active ingredient content of Lot #D2300104 (expiration date 12/31/2025) fell below the approved specification.
The recalled tablets were manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide in the United States. Approximately 4,896 bottles were affected.
Patients who have received the affected lot should contact their healthcare provider to discuss whether their medication batch is affected and to determine the appropriate course of action.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Thyroid Medication
- 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 #D2300104
- Exp Date: 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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