The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0380-2025·Announced 2025-04-30

DoloEar Homeopathic Earache Drops Recalled for cGMP Deviations

Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops (0.50 oz, 15 mL) due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 27,648 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: FDA classified this as Class II. The recall is for manufacturing practice deviations (cGMP), which is a systemic manufacturing concern; however, no specific hazard (such as contamination or harmful ingredient) is identified, and no illnesses or injuries are reported in the source text.

Plain-English summary

Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops, 0.50 oz fl (15 mL), NDC 55758-401-15. The recall was initiated on April 15, 2025, due to cGMP (current Good Manufacturing Practice) deviations. The affected product was distributed in Delaware.

The recall involves 27,648 bottles across two lots: DEE-01 (expiration October 2026) and DEE-02 (expiration February 2027). This is a voluntary recall initiated by the firm and was classified as FDA Class II.

Consumers who have purchased DoloEar Earache Drops should stop use and consult their healthcare provider if they have any concerns about the product. The recall was terminated on January 8, 2026.

The recalled product

Product
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Manufacturer
Pharmadel, LLC
Category
Drug — Homeopathic / Over-the-Counter
Hazard
Affected units
27,648

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
  • expiry: DEE-01
  • EXP: OCT 26
  • DEE-02 EXP: FEB 27

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 →

Related recalls

Same manufacturer · Pharmadel, LLC

See all →

Same hazard · cgmp deviation

See all →

Similar recalls