CLASS II Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops fl recalled
Pharmadel is recalling DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops 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-0379-2025
- 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
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
Where it was distributed
DE
Questions about this recall
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot EDD-01
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 96639This product is part of a recall event; the main page for the event is Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic recalled.