PureLife benzocaine topical anesthetic gel bottles may have incomplete seals
PureLife Topical Anesthetic Gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 450 units are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a container seal defect with no clinical consequence described in the source, which fits the packaging-related Moderate band.
Plain-English summary
PureLife Topical Anesthetic Gel, benzocaine 20%, 1 oz (30 mL), strawberry flavor, manufactured for Pure Life, LLC of Carson, California, NDC 68987-001-30, is being recalled. The action covers 450 units.
The stated reason is a defective container: the product may contain bottles with incomplete seals. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
The affected lot is BNZ-001921, expiring 04/15/2029. Distribution was nationwide in the USA.
Holders of the affected lot should stop using it and follow the instructions issued by the firm.
The recalled product
- Product
- PURELIFE TOPICAL ANESTHETIC (BENZOCAINE)
- Brand
- PURELIFE TOPICAL ANESTHETIC
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical anesthetic gel
- Affected units
- 450
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- BNZ-001921
- EXP 04/15/2029
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Keystone Industries under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Keystone Industries
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Same hazard · defective container
See all →- High
- ModerateQuala Dental benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
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