Drug & medication recalls Moderate risk

DoloEar Earache Drops recalled over manufacturing violations

Recall date
April 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Pharmadel, LLC recalls DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-…
Recall number
D-0380-2025
FDA classification
Class II
Brand / firm
Pharmadel, LLC
Sold / distributed
DE

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

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