Multi-event May 2026 FDA Recall Drug by Pai Holdings Llc

This Multi-event Class II drug recall was voluntarily initiated by Pai Holdings Llc on May 15, 2026 for the product Drug. The FDA reported the reason for recall as does not meet usp or otc monograph. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-0589-2026 ONGOING D-0590-2026 ONGOING D-0591-2026 ONGOING D-0592-2026 ONGOING

Recall Number: D-0589-2026

Reason for Recall
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Initiated
05-15-2026
Reported
06-24-2026
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99000
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PAI Holdings LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : AE001, expires: 5/31/2026.

Recall Number: D-0590-2026

Reason for Recall
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Initiated
05-15-2026
Reported
06-24-2026
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99000
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PAI Holdings LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.

Batch or Lot Expiration Information

Lot# : AE001, expires: 5/31/2026.

Recall Number: D-0591-2026

Reason for Recall
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Initiated
05-15-2026
Reported
06-24-2026
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99000
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PAI Holdings LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : AE006, expires: 5/31/2026

Recall Number: D-0592-2026

Reason for Recall
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Initiated
05-15-2026
Reported
06-24-2026
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99000
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PAI Holdings LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : AH001, expires: 8/31/2026