Recalls / Class II
Class IID-0380-2025
Product
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
- Affected lot / code info
- Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Pharmadel, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Centerpoint Blvd, N/A, Historic New Castle, Delaware 19720-8108
Distribution
- Quantity
- 27,648 bottles
- Distribution pattern
- DE
Timeline
- Recall initiated
- 2025-04-15
- FDA classified
- 2025-04-21
- Posted by FDA
- 2025-04-30
- Terminated
- 2026-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0380-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.