Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated May 21, 2026 (5 months ago)

DHP Topical Anesthetic Gel (Benzocaine)

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

Why it was recalled

Defective container:may contain bottles with incomplete seals

Cause type: Packaging defect

Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.

What was recalled

DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30

Affected NDC 69634-0020-30

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.

ProductStrengthForm & routeLabelerType
Health-Tec Topical Anesthetic
Benzocaine
NDC 69634-0020
200 mg/g Gel
Dental
Dental Health Products, Inc. OTC
Recalling firm
Keystone Industries
NDC code
69634-020-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0602-2026 · 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.

Other Benzocaine recalls

See all
Class II · Moderate risk

safco SensiCaine-Ultra

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 67239-0223-1 D-0606-2026
Class II · Moderate risk

PureLife

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 68987-001-30 D-0605-2026
Class II · Moderate risk

Quala Dental Products

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 43128-034-30 D-0601-2026

Other recalls by Keystone Industries

All 2026 recalls
Class II · Moderate risk

safco SensiCaine-Ultra

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 67239-0223-1 D-0606-2026
Class II · Moderate risk

PureLife

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 68987-001-30 D-0605-2026