Pro Numb Tattoo Numbing Spray Recalled Due to Manufacturing Deviations
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Pro Numb Tattoo Numbing Spray LLC has issued a voluntary recall for specific lots of its 5% Lidocaine spray 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 Tattoo Numbing Spray. The recall was triggered by Current Good Manufacturing Practice (cGMP) deviations. These deviations indicate that the products may not have been manufactured under conditions that ensure their safety, quality, and purity according to federal standards.
Which Products Are Affected
The recall affects the following products distributed nationwide in the United States:
- Product Name: Pro Numb Tattoo Numbing Spray (5% Lidocaine)
- Sizes: 1 FL OZ (28.4 ML) and 4 oz (120 mL) bottles
- NDC Number: 83389-111-11
- Lot Numbers: J01 through J14 and J55 through J69
- Manufacturer: Pro Numb Tattoo Numbing Spray LLC, Melbourne, FL
What You Should Do
Consumers who possess the affected lot numbers should immediately discontinue use of the product. The firm initiated the recall notification via letter on February 2, 2026. Consumers may contact the recalling firm, Pro Numb Tattoo Numbing Spray LLC, at their Palm Bay, Florida location for further instructions regarding the return or disposal of the affected units.
Why This Matters
Adherence to cGMP regulations is critical for ensuring that over-the-counter drugs meet safety and efficacy standards. Deviations from these practices can lead to inconsistencies in the product's strength or potential contamination, posing a risk to consumers using the spray for topical numbing.
Source
This information is based on official recall data provided by the FDA under recall number D-0302-2026.
Original source: FDA Official Notice ↗
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