CLASS II ONGOING Drug recall · Reported 18 Feb 2026 · FDA Enforcement Report

5% Lidocaine, [ or] recalled by Pro Numb Tattoo Numbing Spray

Pro Numb Tattoo Numbing Spray is recalling 5% Lidocaine, [ or] per, distributed nationwide in the US. The recall was initiated on 2 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers J01 through J14, J55 through J69
NDC83389-111
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0302-2026
FDA event ID
98361
Recalling firm
Pro Numb Tattoo Numbing Spray, Palm Bay, FL
Manufacturer
Pro Numb Tattoo Numbing Spray LLC
Classification
Class II
Status
Ongoing
Recall initiated
2 Feb 2026
FDA classified
9 Feb 2026
Reported
18 Feb 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Drug class
Pain Medication

Timeline

2 Feb 2026Recall initiated by company
9 Feb 2026Classified by FDA+7 days
18 Feb 2026Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP deviations

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

cGMP deviations

Which lots are affected?

Lot Numbers J01 through J14, J55 through J69

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98361
ReportedClassRecallCompanyReasonWhere
CLASS IIFor Sensitive Skin, 4% Lidocaine, [ or] recalledPro Numb Sensitive SkinPro Numb Tattoo Numbing SprayManufacturing (CGMP) DeviationsNationwide

More recalls from Pro Numb Tattoo Numbing Spray

All 2
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIFor Sensitive Skin, 4% Lidocaine, [ or] recalledPro Numb Sensitive SkinPro Numb Tattoo Numbing SprayManufacturing (CGMP) DeviationsNationwide