Levothyroxine Sodium 150 mcg Tablets Recalled for Subpotency
Accord Healthcare is recalling 4,921 bottles of Levothyroxine Sodium 150 mcg tablets nationwide due to subpotency—the active ingredient assays below FDA-approved specifications. Patients should consult their prescriber.
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 prescription thyroid medication where the active ingredient assays below approved specification, potentially affecting therapeutic efficacy. Levothyroxine is a critical maintenance medication, but no illnesses or injuries have been reported.
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 150 mcg in 1000-count bottles distributed nationwide. The affected lot is D2300076 with an expiration date of 12/31/2025. Approximately 4,921 bottles have been distributed.
The recall is due to subpotency: the active ingredient assays below the FDA-approved specification. This means some tablets may contain less levothyroxine than labeled.
Levothyroxine is a prescription medication used to treat hypothyroidism and other thyroid conditions. Patients taking affected tablets may not receive the full therapeutic benefit of their medication.
Patients should contact their healthcare provider or pharmacist immediately if they have a prescription filled from affected lot D2300076. Do not stop taking levothyroxine without consulting your prescriber, as hypothyroidism requires continuous treatment. Return any unused tablets from the affected lot to your pharmacy.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- subpotent
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 #D2300076
- 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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