VistaPharm, 50 Grams recall — Pai Holdings LLC (Class II)

Pai Holdings LLC is recorded by the U.S. Food and Drug Administration (FDA) as recalling VistaPharm, 50 Grams — a Class II recall, initiated 2026-05-15 and posted to the FDA enforcement report on 2026-06-24, under recall number D-0592-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023”. From the product description, the strengths given are 50 Grams, 52 Grams and 240 mL and the package is described as 8 fl oz. 1 National Drug Code number is printed in the record: 66689-203-08. Distribution is recorded as “U.S.A. Nationwide” — Nationwide (US), with the recalling firm on record in SC, United States. The FDA files it under event ID 99000 together with 3 other recall numbers, all listed and linked below. Within that event this is the strength 50 Grams · 52 Grams · 240 mL, package 8 fl oz and ndc 66689-203-08 configuration; the sibling records differ on strength, package and ndc and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0592-2026
FDA event ID 99000 (4 recall numbers)
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Pai Holdings LLC
Recall initiated 2026-05-15
Reported by FDA 2026-06-24
Report lag 40 days from initiation to report
Distribution U.S.A. Nationwide — Nationwide (US)
Firm location on record SC, United States
Product description (source) VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.

Reason reported by FDA

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

16 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

6 identifying values matched by exact pattern in the 33-word product description above; each is a literal substring of it.

Product named VistaPharm
Strength 50 Grams · 52 Grams · 240 mL
Package 8 fl oz
NDC 66689-203-08
Distributed by VistaPharm, Inc.

Which configuration this record is

4 recall numbers share event 99000. They differ on strength, package and ndc and agree on everything else the source states, so those are the values to check a package against.

Attribute This record (D-0592-2026) D-0589-2026D-0590-2026D-0591-2026
Strength 50 Grams · 52 Grams · 240 mL 25 Grams · 120 ml50 Grams · 240 ml25 Grams · 26 Grams · 120 mL
Package 8 fl oz 4 fl oz8 fl oz4 fl oz
NDC 66689-203-08 66689-202-0466689-202-0866689-203-04

Shared across all 4 records under this event: product named VistaPharm; fda tier Class II; recalling firm Pai Holdings LLC; the same reason text; initiated 2026-05-15; reported 2026-06-24.

Event context: 4 recall numbers under event 99000

One enforcement action, 4 recall numbers: the FDA filed 3 further configurations of this action under event 99000. Each keeps its own recall number and dates.

Recall recordRecall numberFDA tierStrength / formNDCReported
VistaPharm, 25 GramsD-0589-2026Class II25 Grams66689-202-042026-06-24
VistaPharm, 50 GramsD-0590-2026Class II50 Grams66689-202-082026-06-24
VistaPharm, 25 GramsD-0591-2026Class II25 Grams66689-203-042026-06-24

Reported in the same month (2026-06)

74 enforcement reports carry a report date in 2026-06; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Alyacen 7/7/7, 0.5mg/0.035mgD-0588-2026Glenmark Pharmaceuticals Inc., UsaClass II2026-06-24
Vasopressin 2 Units/2 mL in 0.9% Sodium ChlorideD-0593-2026Integradose Compounding Services LLCClass II2026-06-24
Aripiprazole Tablets USP, 30 mgD-0594-2026Ajanta Pharma Usa IncClass II2026-06-24
Buprenorphine HCl, 0.3 mg/mLD-0596-2026Par Health Usa, LLCClass II2026-06-24
Pearson Quality Topical Anesthetic Gel (20% Benzocaine)D-0600-2026Keystone IndustriesClass II2026-06-24
Quala Dental Products, 20 %D-0601-2026Keystone IndustriesClass II2026-06-24
DHP Topical Anesthetic Gel, 20%D-0602-2026Keystone IndustriesClass II2026-06-24
Burkhart topical anesthetic gel, 20 %D-0603-2026Keystone IndustriesClass II2026-06-24

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 5 nearest to 2026-06-24 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Dental City TOPICAL ANESTHETIC GEL, 20%D-0604-2026Keystone Industries20% · Gel2026-06-24
PureLife, 20%D-0605-2026Keystone Industries20% · Gel2026-06-24
safco SensiCaine-Ultra (20% Benzocaine)D-0606-2026Keystone Industries20% · Gel2026-06-24
Chlorthalidone Tablets, 25 mgD-0610-2026Inventia Healthcare Ltd25 mg · Tablets2026-06-24
Lucky Super Soft, 1%D-0629-2026Dabur India Ltd1% · Cream2026-06-24

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99000 returns all 4 of these recall numbers; a search on D-0592-2026 returns only this configuration. Match a package against 66689-203-08 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Pai Holdings LLC (4 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0592-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0592-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-06-24
Ingested
2026-08-22
Record hash
ba08ac35d12e1976

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.