CLASS II Drug recall · Reported 3 Jul 2013 · FDA Enforcement Report

Ink-eeze Tattoo Numbing Spray, Active Ingredients recalled by Indelicare

Indelicare is recalling Ink-eeze Tattoo Numbing Spray, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, distributed in California, Colorado. The recall was initiated on 23 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot L0207

Quantity recalled683 Bottles

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-621-2013
FDA event ID: 65284
Recalling firm: Indelicare, Newbury Park, CA
Classification: Class II
Status: Terminated
Recall initiated: 23 May 2013
FDA classified: 27 Jun 2013
Reported: 3 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Hidden Drug Ingredients
Drug class: Pain Medication

Timeline

23 May 2013	Recall initiated by company
27 Jun 2013	Classified by FDA	+35 days
3 Jul 2013	Published in enforcement report	+6 days

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

Reason for recall

Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com

Where it was distributed

California and Colorado.

California Colorado

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot L0207

Where was it sold?

California and Colorado.

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 65284

This product is part of a recall event; the main page for the event is Ink-eeze Tattoo Black Label Numbing Spray, a), b) recalled by Indelicare.

Reported	Class	Recall	Company	Reason	Where
3 Jul 2013	CLASS II	Ink-eeze Tattoo Black Label Numbing Spray, a), b) recalled by Indelicare	Indelicare	Hidden Drug Ingredients	CA, CO

More recalls from Indelicare

All 2

Reported	Class	Recall	Company	Reason	Where
3 Jul 2013Drug	CLASS II	Ink-eeze Tattoo Black Label Numbing Spray, a), b) recalled by Indelicare	Indelicare	Hidden Drug Ingredients	CA, CO