Levothyroxine Sodium 300 mcg Tablets Recalled for Subpotency
Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg (90-tablet bottles) nationwide due to subpotency. The affected lot is D2401522 with expiration date 06/2026.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for subpotency (reduced therapeutic efficacy) with no reported illnesses or adverse events. The source text states no reported illnesses or hospitalizations, and subpotency represents a loss of efficacy rather than an acute safety hazard, consistent with a Moderate severity rating.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg) in 90-tablet bottles due to subpotency. The recalled lot is D2401522 with an expiration date of 06/2026. Approximately 6,432 bottles have been distributed nationwide. The product is manufactured by Intas Pharmaceuticals Limited in India and distributed in the United States.
Levothyroxine Sodium is an oral prescription medication used to treat thyroid conditions. If the tablets are subpotent, patients may not receive the full intended therapeutic dose. Consumers who have this medication should not stop taking it without consulting their healthcare provider, as abrupt discontinuation could affect their thyroid treatment.
Patients with this lot should contact their pharmacy or healthcare provider immediately. Healthcare providers and pharmacies should verify if they have received product from lot D2401522 and quarantine it. The FDA has classified this as a Class II recall. The recall was initiated on June 8, 2026, and the firm notified the FDA by letter.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Affected units
- 6,432
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 # D2401522
- Exp Date: 06/2026.
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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