← FDA ENFORCEMENT
D-0380-2025Class II
Pharmadel, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Pharmadel, LLC
Product type
Drug
Status
Terminated
Report date
2025-04-30
Distribution
DE
Firm state
DE
Product quantity
27,648 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations
Product description
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Code / lot info
Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →