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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86486

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 25, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
VistaPharm, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

D-0019-2021
Recall number
D-0019-2021
Initiated
September 25, 2020
Classification
Class III
Status
Terminated
Recalling firm
VistaPharm, Inc.
Quantity
14,244 16 oz bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

Code information

Lots: 638800 Exp 10/21

Distribution pattern

Distributed Nationwide in the USA including Puerto Rico