Multi-event April 2025 FDA Recall Kingskin by Pharmadel, Llc

This Multi-event Class II drug recall was voluntarily initiated by Pharmadel, Llc on April 15, 2025 for the product Kingskin. The FDA reported the reason for recall as cgmp deviations. The product was distributed in DE and the recall is currently terminated.

Reported Recall Events

D-0380-2025 TERMINATED D-0382-2025 TERMINATED D-0383-2025 TERMINATED D-0384-2025 TERMINATED D-0379-2025 TERMINATED D-0381-2025 TERMINATED

Recall Number: D-0380-2025

Reason for Recall
cGMP deviations
Initiated
04-15-2025
Reported
04-30-2025
Quantity
27,648 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96639
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmadel, 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.
DE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2026
Product Description About Product Description
Full technical description of the product.
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

Batch or Lot Expiration Information

Lot# Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27

Recall Number: D-0382-2025

Reason for Recall
cGMP deviations
Initiated
04-15-2025
Reported
04-30-2025
Quantity
6,048 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96639
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmadel, 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.
DE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2026
Product Description About Product Description
Full technical description of the product.
Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02

Batch or Lot Expiration Information

Lot# Lot, expiry: EAG-01, EXP: MAR 27

Recall Number: D-0383-2025

Reason for Recall
cGMP deviations
Initiated
04-15-2025
Reported
04-30-2025
Quantity
6,048 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96639
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmadel, 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.
DE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2026
Product Description About Product Description
Full technical description of the product.
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99

Batch or Lot Expiration Information

Lot# Lot, expiry: EAT-01, EXP: MAR 27

Recall Number: D-0384-2025

Reason for Recall
cGMP deviations
Initiated
04-15-2025
Reported
04-30-2025
Quantity
10,752 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96639
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmadel, 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.
DE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2026
Product Description About Product Description
Full technical description of the product.
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30

Batch or Lot Expiration Information

Lot# Lot, expiry: UDE-01, EXP: OCT 26

Recall Number: D-0379-2025

Reason for Recall
cGMP deviations
Initiated
04-15-2025
Reported
04-30-2025
Quantity
9504 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96639
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmadel, 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.
DE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2026
Product Description About Product Description
Full technical description of the product.
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15

Batch or Lot Expiration Information

Lot# Lot EDD-01

Recall Number: D-0381-2025

Reason for Recall
cGMP deviations
Initiated
04-15-2025
Reported
04-30-2025
Quantity
20,048 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96639
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmadel, 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.
DE
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2026
Product Description About Product Description
Full technical description of the product.
Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

Batch or Lot Expiration Information

Lot# Lot, expiry: KSE-01, EXP: OCT 26; KSE-02, EXP: FEB 27

Affected Packages Involved in this Recall

55758-409-15 Kingskin