CLASS II Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
DoloEar Earache Drops, Homeopathic fl recalled by Pharmadel
Pharmadel is recalling DoloEar Earache Drops, Homeopathic fl, distributed in Delaware. The recall was initiated on 15 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0380-2025
- FDA event ID
- 96639
- Recalling firm
- Pharmadel, Historic New Castle, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2025
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 15 Apr 2025 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +6 days |
| 30 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Where it was distributed
DE
Questions about this recall
Is DoloEar Earache Drops, Homeopathic fl recalled?
Yes. Pharmadel recalled DoloEar Earache Drops, Homeopathic fl on 15 Apr 2025. The recall is Class II and its status is Terminated. Recall number D-0380-2025.
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
Where was it sold?
DE
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pharmadel
All 6Other Doloear earache recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DoloEar Earache Drops recalled by Homeocare Laboratories | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |