Safco Sensicaine Ultra Topical Anesthetic Gel (Benzocaine)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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

safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.

Affected NDC 67239-0219-01

Compare with the code on your package — it is the most precise check available.

Drug: Benzocaine

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
Safco Sensicaine Ultra Topical Anesthetic Gel Benzocaine NDC 67239-0219	200 mg/g	Gel Dental	Safco Dental Supply Co.	OTC

Recalling firm: Keystone Industries
NDC code: 67239-0219-1
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0145-2025 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.