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)

PureLife (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

PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30

Affected NDC 68987-0001-30

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
PureLife Topical Anesthetic
Benzocaine
NDC 68987-0001
200 mg/g Gel
Dental
PureLife Dental OTC
Recalling firm
Keystone Industries
NDC code
68987-001-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0605-2026 · 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

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