Recall archive / FDA drug enforcement

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose... — FDA record D-0440-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 6, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
Reason: CGMP Deviations
Classification: Class II
Recalling firm: Edge Pharma, LLC
Quantity: 221 jars
Agency-reported status: Terminated
Source record identifier: D-0440-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	08-2021-16@12 02-01-2022 09/21/21 - 10/19/21 09-2021-13@8 02-01-2022 11/04/21 - 11/17/21 09-2021-29@8 03-01-2022 10/18/21 - 11/11/21 10-2021-26@7 04-24-2022 11/17/21 - 12/01/21

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 2, 2022
Recall initiation date: Dec 6, 2021
Center classification date: Jan 24, 2022
Termination date: Jun 7, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.