The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0379-2025·Announced 2025-04-30

DoloDent Maximum Strength Toothache Drops Recalled for cGMP Deviations

Pharmadel, LLC is recalling DoloDent Maximum Strength Toothache Drops due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall affects 9,504 bottles distributed in Delaware.

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: This is an FDA Class II recall initiated voluntarily by the firm for manufacturing practice deviations. The source text does not report any illnesses or injuries, making this a precautionary recall without documented harm.

Plain-English summary

Pharmadel, LLC is voluntarily recalling DoloDent Maximum Strength Toothache Drops, a homeopathic oral drop product, due to current Good Manufacturing Practice (cGMP) deviations. The recalled product is 0.50 fl oz (15 mL) bottles with NDC 55758-400-15 and Lot EDD-01.

A total of 9,504 bottles were distributed in Delaware. The recall was initiated by the firm on April 15, 2025, following FDA classification on April 21, 2025. The firm notified customers by letter.

Consumers who have purchased this product should stop using it and contact Pharmadel, LLC for return instructions. The recall has been terminated as of January 8, 2026. For additional information, consumers should contact the FDA's drug recall page or Pharmadel directly.

The recalled product

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
Manufacturer
Pharmadel, LLC
Category
Drug — Homeopathic Oral Drops
Hazard
Affected units
9,504

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 (1)

  • Lot EDD-01

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 6 recalled by Pharmadel, 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 6 products in this recall →

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