VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), dist
Summary
The FDA issued a Class II for VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Acti by PAI Holdings LLC. Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023.
Details
Source
Drug Recall
External ID
D-0589-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
Product Description
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
Lot/Code Info: Lot #: AE001, expires: 5/31/2026.
Reason for Recall
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-15
Company
Greenville, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PAI Holdings LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PAI Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PAI Holdings LLC have FDA actions?
PAI Holdings LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0589-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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