Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Is Benzocaine recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Benzocaine (36 total). Check the affected lots below.
Most common reason: cGMP deviation (16 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzocaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Benzocaine recalls in 2026
7 initiated in 2026, 36 in total — newest first
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Dental City TOPICAL ANESTHETIC GEL
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Burkhart topical anesthetic gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
DHP Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Quala Dental Products
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Pearson Quality Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Optim V
CGMP Deviations
Class II · Moderate risk
Henry Schein
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.
Class II · Moderate risk
Ipana
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.
Class II · Moderate risk
Quala Dental Products
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.
Class II · Moderate risk
safco
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.
Class II · Moderate risk
Pearson Quality
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.
Class II · Moderate risk
Burkhart
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.
Class II · Moderate risk
Health-Tec
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.
Class II · Moderate risk
Dental City
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.
Class II · Moderate risk
Primo
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.
Class II · Moderate risk
M&S Dental Supply Co LLC.
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.
Class II · Moderate risk
Gelato
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.
Class I · High risk
Americaine
Chemical Contamination: presence of benzene
Class III · Low risk
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class II · Moderate risk
Topex (benzocaine 20%)
cGMP deviations: Temperature abuse
Class II · Moderate risk
BLT Topical Cream
CGMP Deviations
Class III · Low risk
Red Cross Oral Pain
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
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