D-0379-2025 Class II Terminated
FDA drug recall D-0379-2025 was initiated by Pharmadel, LLC on April 15, 2025 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated January 8, 2026). Affected quantity: 9504 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- April 15, 2025
- Termination Date
- January 8, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9504 bottles
Product Description
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
Reason for Recall
cGMP deviations
Distribution Pattern
DE
Code Information
Lot EDD-01