Cardinal Health Recalls NURTEC ODT Due to Temperature Excursions
Cardinal Health is recalling NURTEC ODT (rimegepant) tablets due to intermittent exposure to temperature excursions during storage.
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, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a storage condition deviation (temperature excursion) rather than a direct contamination or structural defect, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 1,240 cartons of NURTEC ODT (rimegepant sulfate) 75mg tablets. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific code information for the recalled units is 4170326.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- NURTEC ODT (RIMEGEPANT SULFATE)
- Brand
- NURTEC ODT
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,240
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 (1)
- 4170326
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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