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, Manufactured by VistaPharm, Inc. Largo, FL 33771

Failed Impurities/Degradation Specifications:Out of specification for impurities.

Recall #: D-0348-2019
Affected scope: 4,065,550 5 ml cups
Initiated: November 30, 2018

Compiled from official public sources by the publisher. · Updated September 2026

VistaPharm, Inc. recalled NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 un… - a low-severity action.

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 un… was recalled by VistaPharm, Inc. in December 26, 2018. Reason: Failed Impurities/Degradation Specifications:Out of specification for impurities.. Check the official notice for the remedy. Verify recall #D-0348-2019 with the FDA Drug before acting.

The recall

VistaPharm, Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications:Out of specification for impurities..

Low
severity level: Class III
classification: December 26, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0348-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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, Manufactured by VistaPharm, Inc. Largo, FL 33771

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification for impurities.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-0348-2019
Date reported	December 26, 2018
Date initiated	November 30, 2018
Recalling firm	VistaPharm, Inc.
Firm location	Largo, FL
Affected scope	4,065,550 5 ml cups
Distribution	Nationwide in the USA and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0348-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Failed Impurities/Degradation Specifications:Out of specification for impurities.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on December 26, 2018. Severity: Low. Recall number: D-0348-2019.

Where was the recalled product distributed? ▼

Distribution: Nationwide in the USA and Puerto Rico.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

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Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported December 26, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026