Homeopathic Toothache Drops Recalled Due to Manufacturing Deviations
Pharmadel voluntarily recalled 9,504 bottles of DoloDent Maximum Strength Toothache Drops due to manufacturing practice deviations. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation rather than a known safety threat. Per the rubric, voluntary recalls with no reported harm are classified as Moderate.
Plain-English summary
DoloDent Maximum Strength Toothache Drops, a homeopathic oral product distributed by Pharmadel, LLC (New Castle, Delaware), has been recalled. The product is sold in 0.50 fl oz (15 mL) bottles. The recall affects 9,504 bottles bearing lot code EDD-01, distributed in Delaware.
Pharmadel voluntarily initiated the recall on April 15, 2025, due to manufacturing deviations—specifically, the facility's failure to comply with current Good Manufacturing Practice (cGMP) standards that govern pharmaceutical production. No illnesses or injuries have been reported.
Consumers who possess this product should stop using it immediately and discard it safely. If you have questions about the recall, contact your healthcare provider or pharmacist.
The recalled product
- Product
- 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
- Manufacturer
- Pharmadel, LLC
- Category
- Drug — Homeopathic Oral Drops
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot EDD-01
Distribution
Distributed in 1 state:
- DE
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27