Cardinal Health Recalls Niacin Tablets Due to Temperature Excursions
Cardinal Health is recalling Niacin 250mg tablets due to intermittent temperature excursions during storage. The recall affects 4 bottles distributed in Florida, Georgia, and South Carolina.
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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a storage condition deviation rather than a confirmed contamination or injury.
Plain-English summary
Cardinal Health Inc. is recalling Niacin 250mg tablets (NDC/UPC 740985228494) due to Current Good Manufacturing Practice (CGMP) deviations. The recall is caused by intermittent exposure to temperature excursions during storage.
The recall involves 4 bottles of the product. The affected lots were distributed between February 23, 2021, and March 10, 2021. The products were distributed in Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.
The recalled product
- Product
- NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Over-the-Counter (OTC)
- Hazard
- Affected units
- 4
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)
- All Lots distributed 02/23/2021 through 03/10/2021.
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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