Profound-PE Dental Gel Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.
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 for CGMP deviations—a manufacturing and quality control issue. The source text does not report any illnesses, injuries, or specific safety failures, only procedural manufacturing violations. Under the rubric, Class II recalls without reported harm typically fall in the Moderate range.
Plain-English summary
Edge Pharma, LLC is recalling Profound-PE Dental Gel (Lidocaine HCl / Prilocaine HCl / Tetracaine HCl / Phenylephrin HCl, 10% / 10% / 4% / 2%, Raspberry-Marshmallow flavor) nationwide. The product is a multiple-dose container intended for topical oral use.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. This is a voluntary recall initiated by the firm. Approximately 418 jars were affected across seven different lot codes, distributed between December 2021 and April 2022.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The recall was classified as FDA Class II and was terminated on June 7, 2023.
The recalled product
- Product
- Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Topical Anesthetic
- Affected units
- 418
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 (6)
- 06-2021-29@15 12-26-2021
- 07-2021-12@7 01-08-2022
- 08-2021-03@7 01-30-2022
- 08-2021-25@5 02-01-2022
- 09-2021-10@4 02-01-2022
- 09-2021-22@6 03-01-2022 & 10-2021-06@11 04-04-2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 56 products in this recall →Related recalls
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