Cardinal Health Recalls Ubrelvy Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 964 bottles of Ubrelvy 100mg tablets due to intermittent 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 situation that might cause temporary or medically reversible health consequences. The hazard is a storage condition deviation (temperature excursion) rather than a confirmed contamination or defect causing injury.
Plain-English summary
Cardinal Health Inc. is recalling 964 bottles of Ubrelvy 100mg tablets (NDC 23650110) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific code for the recalled items is 1658641.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 964
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)
- 1658641
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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