FDAClass IIApril 30, 2025

DoloEar Earache Drops recall: CGMP Deviations

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

Why was DoloEar Earache Drops recalled?

cGMP deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27

Product
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Recalling firm
Pharmadel, LLC
Quantity
27,648 bottles
Distribution
DE
Recall date
April 30, 2025
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls