Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 25 mcg tablets nationwide because they are subpotent.
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: The recall is classified as FDA Class II for a subpotent drug. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles. The recall is initiated because the affected drug products are subpotent, meaning they do not contain the full labeled amount of the active ingredient. The products are manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide within the United States.
The recall affects specific lots with expiration dates ranging from August 31, 2026, to January 31, 2027. The affected lot numbers are D2401927, D2401833, D2402551, D2402552, D2500220, and D2500223. The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory or prescriptions for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should not be used. Patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement medication.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Prescription Drug
- 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 (10)
- Lot #: D2401927
- D2401833
- Exp. Date 08/31/2026
- D2402551
- D2402552
- Exp. Date 11/30/2026
- D2500220
- Exp. Date 12/31/2026
- D2500223
- Exp. Date 01/31/2027.
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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