Pro Numb Spray
FDA Recall NDC 83389-111
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pro Numb (NDC 83389-111). A significant event, classified as Class II, was initiated on Feb 02, 2026 by Pro Numb Tattoo Numbing Spray Llc. The reported reason for this action was: "cGMP deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP deviations
Feb 02, 2026
Feb 18, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98361
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pro Numb Tattoo Numbing Spray LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
Batch or Lot Expiration Information
Lot# Lot Numbers J01 through J14, J55 through J69
Affected Packages Involved in this Recall
83389-111-11Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
