Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Pro Numb Tattoo Numbing Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
83389-0111-11
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pro Numb Tattoo Numbing Spray NDC 83389-0111 |
EPINEPHRINE HYDROCHLORIDE .1 mg/100mL; LIDOCAINE HYDROCHLORIDE 5 mg/100mL | Spray Topical |
Pro Numb Tattoo Numbing Spray LLC | OTC |
- Recalling firm
- Pro Numb Tattoo Numbing Spray LLC
- NDC code
- 83389-111-11
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0302-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class III · Low risk
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Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Other recalls by Pro Numb Tattoo Numbing Spray LLC
All 2026 recalls
Class II · Moderate risk
Pro Numb Tattoo Numbing Spray
cGMP deviations
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