Recall events
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Event 85888
Event summary
Timeline bucket June 23, 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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
2 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 2
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
D-1377-2020
Recall number D-1377-2020
Initiated June 23, 2020
Classification Class III
Status Terminated
Quantity 380,700 cups
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Code information Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
Distribution pattern United States including Puerto Rico
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14757]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
D-1378-2020
Recall number D-1378-2020
Initiated June 23, 2020
Classification Class III
Status Terminated
Quantity 14,760 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Code information Lot # 639000, Exp. 10/31/2021
Distribution pattern United States including Puerto Rico
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14394]
FDA event record
· Exact recall-number query on openFDA
