VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Test Failures
VistaPharm is recalling Nystatin Oral Suspension because it failed impurity and degradation specifications. The affected product is distributed nationwide.
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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP 500,000 units/5 mL (NDC 66689-037-01). The recall involves 1,707,050 cups of the prescription medication, which is distributed nationwide.
The recall was initiated due to failed impurities and degradation specifications, specifically a test failure of the single largest peak at 18 months. The affected lots are #240200, 243000, 244800, 245600, 250800, and 253600, all with an expiration date of 06/13.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Antifungal
- Hazard
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 (5)
- Lot # 240200
- 243000
- 244800
- 245600
- 250800 and 253600. Exp 06/13.
Distribution
Distributed nationwide across the United States.
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