Medications & Supplements/Over-the-Counter

DoloDent, DoloEar, and Other Pharmadel Products Recalled for cGMP Deviations

Agency Publication Date: April 21, 2025

Summary

Pharmadel, LLC is recalling 80,048 bottles and packages of various homeopathic products, including DoloDent Toothache Drops, DoloEar Earache Drops, Kingskin Wart Remover, Rapidol Arnica Gel, Rapidol Arnica Tablets, and Urodel UTI Relief tablets. This voluntary recall was initiated due to manufacturing process deviations (cGMP deviations) that could impact the quality and safety of the medications. Consumers should consult a healthcare professional if they have used these products and have health concerns.

Risk

Deviations in manufacturing standards can lead to drug products that are contaminated or do not meet potency and safety requirements, potentially resulting in ineffective treatment or adverse health reactions.

What You Should Do

This recall affects various homeopathic drug products distributed by Pharmadel, LLC, including DoloDent Maximum Strength Toothache Drops, DoloEar Earache Drops, Kingskin Wart Remover, Rapidol Arnica Gel and Tablets, and Urodel Urinary Tract Relief tablets.
Check your product packaging for the following lot numbers and expiration dates: EDD-01, DEE-01 (Exp Oct 26), DEE-02 (Exp Feb 27), KSE-01 (Exp Oct 26), KSE-02 (Exp Feb 27), EAG-01 (Exp Mar 27), EAT-01 (Exp Mar 27), or UDE-01 (Exp Oct 26).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Pharmadel, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: DoloDent Maximum Strength Toothache Drops (0.50 oz fl / 15 mL)

Variants: Homeopathic Oral Drops

Lot Numbers:

EDD-01

NDC:

55758-400-15

Product: DoloEar Earache Drops (0.50 oz fl / 15 mL)

Variants: Homeopathic

Lot Numbers:

DEE-01 (Exp OCT 26)

DEE-02 (Exp FEB 27)

NDC:

55758-401-15

Product: Kingskin Wart Remover (0.50 oz fl / 15 mL)

Variants: Elimina Las Verrugas

Lot Numbers:

KSE-01 (Exp OCT 26)

KSE-02 (Exp FEB 27)

NDC:

55758-409-15

Product: Rapidol Arnica Gel (2 oz / 57 g)

Variants: Topical Gel, Homeopathic Medicine

Lot Numbers:

EAG-01 (Exp MAR 27)

NDC:

55758-403-02

Product: Rapidol Arnica Tablets (100-count)

Variants: Homeopathic Medicine

Lot Numbers:

EAT-01 (Exp MAR 27)

NDC:

55758-405-99

Product: Urodel Urinary Tract Infection Symptoms Relief (30 chewable tablets)

Variants: Homeopathic

Lot Numbers:

UDE-01 (Exp OCT 26)

NDC:

55758-406-30

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96639

Status: Resolved

Manufacturer: Pharmadel, LLC

Sold By: Retailers in Delaware

Manufactured In: United States

Units Affected: 6 products (9504 bottles; 27,648 bottles; 20,048 bottles; 6,048 bottles; 6,048 bottles; 10,752 bottles)

Distributed To: Delaware

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects various homeopathic drug products distributed by Pharmadel, LLC, including DoloDent Maximum Strength Toothache Drops, DoloEar Earache Drops, Kingskin Wart Remover, Rapidol Arnica Gel and Tablets, and Urodel Urinary Tract Relief tablets.

Check your product packaging for the following lot numbers and expiration dates: EDD-01, DEE-01 (Exp Oct 26), DEE-02 (Exp Feb 27), KSE-01 (Exp Oct 26), KSE-02 (Exp Feb 27), EAG-01 (Exp Mar 27), EAT-01 (Exp Mar 27), or UDE-01 (Exp Oct 26).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Pharmadel, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: DoloDent Maximum Strength Toothache Drops (0.50 oz fl / 15 mL)

Variants: Homeopathic Oral Drops

Lot Numbers:

EDD-01

NDC:

55758-400-15

Product: DoloEar Earache Drops (0.50 oz fl / 15 mL)

Variants: Homeopathic

Lot Numbers:

DEE-01 (Exp OCT 26)

DEE-02 (Exp FEB 27)

NDC:

55758-401-15

Product: Kingskin Wart Remover (0.50 oz fl / 15 mL)

Variants: Elimina Las Verrugas

Lot Numbers:

KSE-01 (Exp OCT 26)

KSE-02 (Exp FEB 27)

NDC:

55758-409-15

Product: Rapidol Arnica Gel (2 oz / 57 g)

Variants: Topical Gel, Homeopathic Medicine

Lot Numbers:

EAG-01 (Exp MAR 27)

NDC:

55758-403-02

Product: Rapidol Arnica Tablets (100-count)

Variants: Homeopathic Medicine

Lot Numbers:

EAT-01 (Exp MAR 27)

NDC:

55758-405-99

Product: Urodel Urinary Tract Infection Symptoms Relief (30 chewable tablets)

Variants: Homeopathic

Lot Numbers:

UDE-01 (Exp OCT 26)

NDC:

55758-406-30

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96639

Status: Resolved

Manufacturer: Pharmadel, LLC

Sold By: Retailers in Delaware

Manufactured In: United States

Units Affected: 6 products (9504 bottles; 27,648 bottles; 20,048 bottles; 6,048 bottles; 6,048 bottles; 10,752 bottles)

Distributed To: Delaware