Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 112 mcg tablets because they are subpotent. The recall covers nationwide distribution.
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. The hazard is a subpotent drug, which poses a risk of therapeutic failure for a chronic condition, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles. The recall is initiated because the product is subpotent, meaning it may not contain the full labeled amount of the active ingredient. The affected product is manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide within the United States.
The recall affects specific lots with expiration date 10/31/2026. The lot numbers are D2402443, D2402444, and D2402445. The NDC for the affected package is 16729-452-17. The recall was initiated on August 6, 2026, and is currently ongoing.
Patients and consumers should check their medication bottles for the lot numbers and expiration date listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement therapy. The recall was classified as Class II by the FDA.
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 (4)
- Lot #: D2402443
- D2402444
- D2402445
- Exp. Date 10/31/2026.
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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