Cardinal Health Recalls Nadolol Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 40 bottles of Nadolol 40 mg 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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves storage conditions rather than a direct contamination or mislabeling of a common allergen.
Plain-English summary
Cardinal Health Inc. is recalling 40 bottles of Nadolol Tablets, USP 40 mg. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product is identified by the code NB100156 and NDC 69097-868-07. The tablets were distributed in Florida, Georgia, and South Carolina. The product was manufactured for Cipla USA Inc.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- NADOLOL (NADOLOL)
- Brand
- NADOLOL
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 40
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)
- NB100156
UPCs (3)
- 0369097867072
- 0369097869076
- 0369097868079
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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