PureLife, 20% recall — Keystone Industries (Class II)

Keystone Industries is recorded by the U.S. Food and Drug Administration (FDA) as recalling PureLife, 20% — a Class II recall, initiated 2026-05-21 and posted to the FDA enforcement report on 2026-06-24, under recall number D-0605-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Defective container:may contain bottles with incomplete seals”. From the product description, the form is gel and the strengths given are 20% and 30mL. 1 National Drug Code number is printed in the record: 68987-001-30. Distribution is recorded as “Nationwide in the USA” — Nationwide (US), with the recalling firm on record in NJ, United States. The FDA files it under event ID 99076 together with 6 other recall numbers, all listed and linked below. Within that event this is the strength 20% · 30mL, ndc 68987-001-30 and product named PureLife configuration; the sibling records differ on strength, ndc and product named and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0605-2026
FDA event ID 99076 (7 recall numbers)
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Keystone Industries
Recall initiated 2026-05-21
Reported by FDA 2026-06-24
Report lag 34 days from initiation to report
Distribution Nationwide in the USA — Nationwide (US)
Firm location on record NJ, United States
Product description (source) 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

Reason reported by FDA

Defective container:may contain bottles with incomplete seals

7 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

4 identifying values matched by exact pattern in the 25-word product description above; each is a literal substring of it.

Product named PureLife
Form Gel
Strength 20% · 30mL
NDC 68987-001-30

Which configuration this record is

7 recall numbers share event 99076. They differ on strength, ndc and product named and agree on everything else the source states, so those are the values to check a package against.

Attribute This record (D-0605-2026) D-0600-2026D-0601-2026D-0602-2026D-0603-2026D-0604-2026D-0606-2026
Strength 20% · 30mL 20%20 % · 30 g20% · 30 g20 % · 30 mL20% · 30 g20% · 29.6mL
NDC 68987-001-30 43305-0009-343128-034-3069634-020-3043498-310-3069483-001-3067239-0223-1
Product named PureLife Pearson Quality Topical Anesthetic Gel (20% Benzocaine)Quala Dental ProductsDHP Topical Anesthetic GelBurkhart topical anesthetic gelDental City TOPICAL ANESTHETIC GELsafco SensiCaine-Ultra (20% Benzocaine)

Shared across all 7 records under this event: form Gel; fda tier Class II; recalling firm Keystone Industries; the same reason text; initiated 2026-05-21; reported 2026-06-24.

Event context: 7 recall numbers under event 99076

One enforcement action, 7 recall numbers: the FDA filed 6 further configurations of this action under event 99076. Each keeps its own recall number and dates.

Recall recordRecall numberFDA tierStrength / formNDCReported
Pearson Quality Topical Anesthetic Gel (20% Benzocaine)D-0600-2026Class II20% · Gel43305-0009-32026-06-24
Quala Dental Products, 20 %D-0601-2026Class II20 % · Gel43128-034-302026-06-24
DHP Topical Anesthetic Gel, 20%D-0602-2026Class II20% · Gel69634-020-302026-06-24
Burkhart topical anesthetic gel, 20 %D-0603-2026Class II20 % · Gel43498-310-302026-06-24
Dental City TOPICAL ANESTHETIC GEL, 20%D-0604-2026Class II20% · Gel69483-001-302026-06-24
safco SensiCaine-Ultra (20% Benzocaine)D-0606-2026Class II20% · Gel67239-0223-12026-06-24

Reported in the same month (2026-06)

74 enforcement reports carry a report date in 2026-06; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Alyacen 7/7/7, 0.5mg/0.035mgD-0588-2026Glenmark Pharmaceuticals Inc., UsaClass II2026-06-24
VistaPharm, 25 GramsD-0589-2026Pai Holdings LLCClass II2026-06-24
VistaPharm, 50 GramsD-0590-2026Pai Holdings LLCClass II2026-06-24
VistaPharm, 25 GramsD-0591-2026Pai Holdings LLCClass II2026-06-24
VistaPharm, 50 GramsD-0592-2026Pai Holdings LLCClass II2026-06-24
Vasopressin 2 Units/2 mL in 0.9% Sodium ChlorideD-0593-2026Integradose Compounding Services LLCClass II2026-06-24
Aripiprazole Tablets USP, 30 mgD-0594-2026Ajanta Pharma Usa IncClass II2026-06-24
Buprenorphine HCl, 0.3 mg/mLD-0596-2026Par Health Usa, LLCClass II2026-06-24

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 2 nearest to 2026-06-24 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Chlorthalidone Tablets, 25 mgD-0610-2026Inventia Healthcare Ltd25 mg · Tablets2026-06-24
Lucky Super Soft, 1%D-0629-2026Dabur India Ltd1% · Cream2026-06-24

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99076 returns all 7 of these recall numbers; a search on D-0605-2026 returns only this configuration. Match a package against 68987-001-30 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Keystone Industries (7 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0605-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0605-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-06-24
Ingested
2026-08-22
Record hash
97fd6091e3770ded

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.