Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 75 mcg tablets nationwide because they may contain less than the labeled amount of active ingredient.
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 and involves a subpotent prescription drug, which poses a risk of therapeutic failure for patients managing thyroid conditions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles. The recall is limited to lots D2402016 and D2402017, which have an expiration date of 08/31/2026. The product is identified by NDC 16729-449-17 and was manufactured by Intas Pharmaceuticals Limited in India.
The reason for the recall is that the affected tablets are subpotent, meaning they may not contain the full labeled amount of the active drug ingredient. The recall was initiated by the firm on August 6, 2026, and is currently ongoing. The FDA has classified this as a Class II recall.
The affected product was distributed nationwide within the United States. Patients who have been prescribed Levothyroxine Sodium should check their medication bottles for the specific lot numbers and expiration date listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
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 (3)
- Lot #: D2402016
- D2402017
- Exp. Date 08/31/2026
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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