Levothyroxine sodium 25 microgram tablets assayed below the approved specification
Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.
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: 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, 25 mcg (0.025 mg), 90-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 82,159 bottles.
The stated reason is a subpotent drug: the assay is below the approved specification. The FDA classified the action as Class II.
Affected lots are D2300325 expiring 01/31/2026 and D2400536 expiring 02/28/2026. Distribution was nationwide in the USA.
Patients holding affected lots 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
- 82,159
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 #D2300325
- Exp Date: 01/31/2026
- Lot #D2400536
- Exp Date: 02/28/2026
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
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