VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Failures
VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups. The recall was initiated because the product failed impurities/degradation specifications, specifically being out of specification for impurities.
The affected product is packaged in 50 or 100 unit dose cups and is distributed nationwide in the USA and Puerto Rico. Specific lot numbers and expiration dates are listed in the recall documentation.
Consumers should check their medication for the affected NDC codes and lot numbers. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only…
- 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 (11)
- Lots: a) 505300 Exp. Dec 2018
- 522200 Exp. Apr 2019
- 534400 Exp. Jul 2019
- 539000 Exp. Aug 2019
- 543400 Exp. Sep 2019
- b) 523600
- 522200X Exp. Apr 2019
- 535500 Exp. Jul 2019
- 540700 Exp. Aug 2019
- 543300 Exp. Sep 2019
- 550100 Exp. Oct 2019.
Distribution
Related recalls
Same manufacturer · VistaPharm, Inc.
See all →- ModeratePrescription pyridostigmine bromide oral solution recalled for out-of-specification preservative
FDA (Drugs) · 2022-11-02
- ModerateClobazam Oral Suspension Recalled for Failed Stability Specifications
FDA (Drugs) · 2022-01-26
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity
FDA (Drugs) · 2020-10-14
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak
FDA (Drugs) · 2020-07-15
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications
FDA (Drugs) · 2020-07-15
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateVistaPharm Recalls Nystatin Oral Suspension Due to Impurity
FDA (Drugs) · 2017-06-07
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak
FDA (Drugs) · 2020-07-15
- ModerateVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Test Failures
FDA (Drugs) · 2013-08-28
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications
FDA (Drugs) · 2020-07-15
- SevereVistaPharm Recalls Nystatin Oral Suspension Due to Water Contamination
FDA (Drugs) · 2017-02-08
- SevereVistaPharm Recalls Phenytoin Oral Suspension Due to Container Defects
FDA (Drugs) · 2013-12-18