FDA Drugs recall ·
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL)… recall
- Recall number
- D-0380-2025
- Date
- (initiated April 15, 2025)
- Company / brand
- Pharmadel, LLC
650 Centerpoint Blvd, Historic New Castle, DE, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 27,648 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Why was it recalled?
cGMP deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
Distribution
DE
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0380-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.