Levothyroxine sodium 150 microgram tablets assayed below the approved specification
Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.
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: Risk-of-harm product: a subpotent thyroid hormone tablet may under-treat the condition it is prescribed for, with no injury reported in the source.
Plain-English summary
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, prescription only, manufactured for Accord Healthcare, Inc. of Raleigh, North Carolina by Intas Pharmaceuticals Limited of Dehradun, India, are being recalled. The action covers 4,921 bottles.
The stated reason is a subpotent drug: the assay is below the approved specification. The FDA classified the action as Class II.
The affected lot is D2300076, expiring 12/31/2025. Distribution was nationwide in the USA.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Accord Healthcare.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Oral tablet
- Affected units
- 4,921
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.
Part of a larger recall action
This product is one of 7 recalled by ACCORD HEALTHCARE, INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same brand · LEVOTHYROXINE SODIUM
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