Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium tablets because they may contain less active ingredient than labeled.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant health risks, such as subpotent drugs that may lead to treatment failure, are categorized as Severe (Score 4).
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles. The recall was initiated on August 6, 2026, and is classified as Class II by the FDA. The affected product is manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide within the United States.
The reason for the recall is that the tablets are subpotent, meaning they may contain less than the labeled amount of the active ingredient, levothyroxine sodium. This can result in patients not receiving the intended therapeutic dose. The specific lots affected are D2401813 and D2401814 with an expiration date of 08/31/2026, and D2500200 and D2500219 with an expiration date of 12/31/2026.
Patients who have been prescribed this medication should check their bottles for the lot numbers and expiration dates listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is ongoing, and the firm has notified customers via letter.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Prescription Medication
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 (6)
- Lot #: D2401813
- D2401814
- Exp. Date 08/31/2026
- D2500200
- D2500219
- Exp. Date 12/31/2026.
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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