FDA Recalls Nystatin Oral Suspension Due to Subpotent Drug Levels
Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it failed potency testing. Patients should consult their healthcare provider.
What this means for you
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 corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported, representing a risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL). The recall involves 7,416 bottles of Lot B973, which has an expiration date of 11/20. The product was distributed nationwide in the United States.
The recall was initiated because the drug was found to be subpotent, meaning it was out of specification for assay at the 15-month test interval. This indicates the medication may not contain the full amount of the active ingredient required to be effective.
Patients who have this specific lot of Nystatin should consult their healthcare provider or pharmacist for guidance on whether to continue using the medication or obtain a replacement. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NYSTATIN (NYSTATIN)
- Brand
- NYSTATIN
- Category
- Drug — Antifungal
- Hazard
- Affected units
- 7,416
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 (2)
- Lot: B973
- Exp 11/20
UPCs (1)
- 0301210810022
Distribution
Distributed nationwide across the United States.
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