The Recall Desk
ModerateFDA (Drugs)·D-0884-2023·Announced 2023-07-05

Drug earache drops recalled due to manufacturing practice deviations

DoloEar Earache Drops are being recalled due to manufacturing practice deviations. Homeocare Laboratories voluntarily initiated the recall, which was terminated in September 2024.

What this means for you

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 with no reported illnesses or injuries. The recall was voluntary and precautionary, based on manufacturing deviations rather than a confirmed contamination or adverse event. Voluntary precautionary recalls without reported harm meet the criteria for Moderate severity.

Plain-English summary

DoloEar Earache Drops, 0.50 fl. oz. bottles, manufactured by Homeocare Laboratories, Inc. and distributed by Pharmadel LLC in Georgetown, Delaware, are being recalled due to deviations from current Good Manufacturing Practice (cGMP) standards.

Approximately 12,850 bottles were distributed nationwide across the United States. The affected product includes Lot # 2423 (expiration date November 2024) and Lot # 2445 (expiration date April 2025), identified by NDC 55758-001-15.

Homeocare Laboratories voluntarily initiated the recall on June 5, 2023, following FDA notification on June 26, 2023. The recall was terminated on September 16, 2024. Consumers who have purchased affected lots should stop using the product and consult their healthcare provider if they have taken this medication.

The recalled product

Product
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Manufacturer
Homeocare Laboratories, Inc.
Category
Drug — Otic
Hazard
Affected units
12,850

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 (4)

  • Lot # 2423
  • exp. date Nov-24
  • 2445
  • exp. date Apr-25

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Homeocare Laboratories, Inc. 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 11 products in this recall →

Related recalls

Same manufacturer · Homeocare Laboratories, Inc.

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Same hazard · manufacturing deviation

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