Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 125 mcg tablets because they are subpotent. The recall is ongoing nationwide.
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: 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, 125 mcg (0.125 mg), 1000-count bottles. The recall was initiated on August 6, 2026, and is currently ongoing. 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 drug is subpotent, meaning it may not contain the full labeled amount of the active ingredient. The FDA has classified this recall as Class II, which indicates a situation that could cause temporary or medically reversible health consequences. The specific lots affected are D2401983 (Exp. 08/31/2026), D2402640 and D2402641 (Exp. 11/30/2026), and D2500224 (Exp. 01/31/2027).
Consumers and healthcare providers should check their medication bottles for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or contact Accord Healthcare for instructions. The recall number is D-0781-2026.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Prescription Medication
- 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 (7)
- Lot #: D2401983
- Exp. Date 08/31/2026
- D2402640
- D2402641
- Exp. Date 11/30/2026
- D2500224
- 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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