Kerr Insta-Char activated charcoal suspension did not meet OTC monograph
VistaPharm Kerr Insta-Char activated charcoal in a sorbitol base with cherry flavor is being recalled because the product did not meet the Over-the-Counter Monograph M023.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for failure to meet an OTC monograph with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
Kerr Insta-Char in a Sorbitol Base with Cherry Flavor, 25 grams activated charcoal in 26 grams sorbitol in 120 mL (4 fl oz), distributed by VistaPharm, Inc. of Largo, Florida, NDC 66689-203-04, is being recalled.
The stated reason is that the product does not meet USP or the OTC Monograph: it did not meet Over-the-Counter Monograph M023. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
The affected lot is AE006, expiring 5/31/2026. Distribution was USA nationwide.
Holders of the affected lot should stop using it and follow the instructions issued by the firm.
The recalled product
- Product
- VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.
- Manufacturer
- PAI Holdings LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AE006
- expires: 5/31/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by PAI Holdings LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · PAI Holdings LLC
See all →- ModerateKerr Insta-Char aqueous charcoal suspension did not meet OTC monograph
FDA (Drugs) · 2026-06-24
- ModerateKerr Insta-Char 50 gram charcoal suspension did not meet OTC monograph
FDA (Drugs) · 2026-06-24
- ModerateKerr Insta-Char 25 gram aqueous suspension did not meet OTC monograph
FDA (Drugs) · 2026-06-24
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