PureLife Topical Anesthetic Gel Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Keystone Industries is recalling 450 units of PureLife Topical Anesthetic Gel due to defective containers that may have incomplete seals.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 1, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drug.

What Happened

Keystone Industries initiated a voluntary recall of PureLife Topical Anesthetic Gel after determining that the product may contain bottles with incomplete seals.

Which Products Are Affected

PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor. NDC 68987-001-30. Lot code BNZ-001921, EXP 04/15/2029. A total of 450 units were distributed nationwide in the USA.

What You Should Do

Consumers should check product lot information against the recalled code. The recall was initiated by letter from the firm.

Why This Matters

This Class II recall involves a nationwide distribution of 450 units of a dental topical anesthetic that may have defective container seals.

Source

FDA recall number D-0605-2026. https://www.fda.gov

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Keystone Industries is recalling 450 units of PureLife Topical Anesthetic Gel due to defective containers that may have incomplete seals.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.