Pro Numb Tattoo Numbing Spray Recalled Nationwide Due to Manufacturing Deviations

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

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 this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.

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).

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall 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 updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.