Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 150 mcg 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 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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. It is a voluntary recall for a subpotent drug, which fits the criteria for a moderate severity rating involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles. The recall is limited to specific lots with expiration date 09/30/2026. The product is distributed nationwide within the United States.
The reason for the recall is that the tablets are subpotent, meaning they may contain less of the active ingredient than stated on the label. Levothyroxine is a prescription medication used to treat hypothyroidism. If the medication does not contain the correct amount of active ingredient, it may not effectively manage the condition for which it was prescribed.
Patients who have been prescribed this medication should check their bottles for the affected lot numbers (D2402195, D2402196, or D2402197) and expiration date. If the medication matches these details, patients should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement prescription.
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 (4)
- Lot #: D2402195
- D2402196
- D2402197
- Exp. Date 09/30/2026.
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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