Pro Numb Tattoo Numbing Spray Recalled Nationwide Due to Manufacturing Deviations

FDA Recalls medium FDA · · United States

Pro Numb Tattoo Numbing Spray LLC has voluntarily recalled its Pro Numb Sensitive Skin spray (Lot J15) due to Current Good Manufacturing Practice (cGMP) deviations.

What Happened

Pro Numb Tattoo Numbing Spray LLC has initiated a voluntary recall of its Pro Numb Sensitive Skin numbing spray. The U.S. Food and Drug Administration (FDA) has designated this as a Class II recall following the discovery of Current Good Manufacturing Practice (cGMP) deviations. The recall was officially initiated on February 2, 2026.

Which Products Are Affected

The recall involves specific lots of the following topical drug product distributed nationwide across the United States:

  • Product Name: Pro Numb Tattoo Numbing Spray, For Sensitive Skin (4% Lidocaine)
  • Sizes: 1 FL OZ (28.4 mL) or 4 oz (120 mL) bottles
  • NDC Number: 83389-112-11
  • Lot Number: J15
  • Recall Number: D-0303-2026
  • Manufacturer: Pro Numb Tattoo Numbing Spray LLC, based in Palm Bay/Melbourne, FL.

What You Should Do

Consumers who have purchased the affected Pro Numb Tattoo Numbing Spray from Lot J15 should stop using the product immediately. The manufacturer initiated the recall process via notification letters. Consumers seeking information regarding returns or refunds should contact Pro Numb Tattoo Numbing Spray LLC directly at their Palm Bay, Florida, location.

Why This Matters

Adherence to Current Good Manufacturing Practices (cGMP) is essential to ensure that over-the-counter drug products meet the necessary standards for safety, quality, and purity. Deviations from these practices can compromise the integrity of the medication.

Source

This report is based on official recall documentation provided by the U.S. Food and Drug Administration (FDA).

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
Pro Numb Tattoo Numbing Spray LLC has voluntarily recalled its Pro Numb Sensitive Skin spray (Lot J15) due to Current Good Manufacturing Practice (cGMP) deviations.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.