Sandoz Recalls Nadolol Tablets Due to Failed Dissolution Test
Sandoz Incorporated is recalling 96 bottles of Nadolol Tablets, 40mg, because the product failed a required dissolution test.
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 issues. The hazard is a failure to meet a quality specification (dissolution) rather than a direct contamination or acute injury risk.
Plain-English summary
Sandoz Incorporated is recalling 96 bottles of Nadolol Tablets, USP, 40mg, packaged in 1000-count bottles. The specific lot affected is GG1539, with NDC 0781-1182-10. The product is a prescription-only medication manufactured by Sandoz Inc. in Princeton, NJ.
The recall was initiated because the medication failed a dissolution specification test. The test result was 40%, which is below the required minimum of 80%. This means the tablets may not dissolve properly in the body, potentially affecting how the medication works.
The affected product was distributed to Mississippi and Ohio. Patients who have this specific lot of Nadolol should contact their healthcare provider or pharmacist for guidance on what to do next.
The recalled product
- Product
- Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 96
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)
- Lot GG1539
Distribution
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