Home/Recalls/FDA-D-0606-2026
FDA DrugsClass II

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flav...

Published: June 24, 2026Recall ID: D-0606-2026Category: drugsCountry: US

Reason for Recall / Hazard

Defective container:may contain bottles with incomplete seals

Product Description & Identification

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.

Affected Products

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.

Additional Source Details

FieldValue
CityGibbstown
StateNJ
Openfda › Nui › 1N0000185508
Openfda › Nui › 2N0000175629
Openfda › Nui › 3N0000184306
Openfda › Nui › 4M0000728
Openfda › UniiU3RSY48JW5
Openfda › RouteDENTAL
Openfda › Rxcui238910
Openfda › Spl id2b3abb36-2cdf-b478-e063-6294a90a4f45
Openfda › Brand nameSAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL
Openfda › Spl set id923636fb-8f9a-480b-e053-2995a90a618e
Openfda › Package ndc67239-0223-1
Openfda › Product ndc67239-0223
Openfda › Generic nameBENZOCAINE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Pharm class csAllergens [CS]
Openfda › Pharm class pe › 1Increased Histamine Release [PE]
Openfda › Pharm class pe › 2Cell-mediated Immunity [PE]
Openfda › Substance nameBENZOCAINE
Openfda › Pharm class epcStandardized Chemical Allergen [EPC]
Openfda › Manufacturer nameSafco Dental Supply Co.
Openfda › Application numberM022
Openfda › Is original packagertrue
Event id99076
Address 1480 S Democrat Rd
Code infoBNZ-001921, Exp 04/15/2029
Postal code08027-1239
Report date20260624
Product typeDrugs
Product quantity150 units
Reason for recallDefective container:may contain bottles with incomplete seals
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260521
Initial firm notificationLetter
Center classification date20260618

Overview

  • Recalling FirmKeystone Industries
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide in the USA
Official Agency Alert