Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0441-2022·Announced 2022-02-02

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard: cgmp-deviation
manufacturing-defect
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 →

Same manufacturer · Edge Pharma, LLC

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Same hazard · cgmp deviation