Pharmadel recalls DoloDent Maximum Strength Toothache Drops due to cGMP deviations. This affects specific lot numbers and sizes. Consumers should check their product details.
cGMP deviations
Pharmadel is recalling DoloD: Maximum Strength Toothache Drops because of manufacturing quality issues. This recall is for specific lot numbers and sizes, but the product is not dangerous in normal use.
The product was made with cGMP deviations, which means the manufacturing process did not follow quality standards. This could lead to inconsistent product quality, but it does not cause immediate harm or injury in normal use.
People who own or use DoloDent Maximum Strength Toothache Drops with the specific lot number EDD-01 and size 0.50 oz fl (15 mL) are affected. Those using the product for toothache relief are most at risk.
Check for the product name 'DoloDent Maximum Strength Toothache Drops', size 0.50 oz fl (15 mL), and lot number EDD-01. The product was distributed by Pharmadel, LLC from New Castle, DE.
Look for the specific lot number EDD-01 and size 0.50 oz fl (15 mL) on the product label.
The recall is due to cGMP deviations, which means the product may not meet quality standards, but it does not cause immediate harm or injury in normal use.
Check the product details to see if it matches the recalled lot number EDD-01 and size 0.50 oz fl (15 mL). If it does, contact Pharmadel for further instructions.
The recall record does not mention a replacement option. Consumers should check with Pharmadel for specific instructions.
We’ve drafted a message you can send Pharmadel to request your refund or repair — edit it as you like.
Subject: Recall D-0379-2025 — Pharmadel Pharmadel Hello, I own a Pharmadel that is covered by recall D-0379-2025 from Pharmadel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
