Cardinal Health Recalls Desvenlafaxine Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 57 bottles of Desvenlafaxine Extended-Release Tablets 25 mg 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, and the hazard involves storage conditions (temperature excursions) which is a lower-risk contamination or quality issue compared to active ingredient errors or high-risk pathogens.
Plain-English summary
Cardinal Health Inc. is recalling 57 bottles of Desvenlafaxine Extended-Release Tablets 25 mg (NDC 0591-4060-30). The product was manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc.
The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers should check their medication for the specific NDC and lot code 1399650A. If the product matches the recalled description, they should contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- DESVENLAFAXINE (DESVENLAFAXINE)
- Brand
- DESVENLAFAXINE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 57
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)
- 1399650A
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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