Lower risk Drug recall · FDA · Published May 21, 2026

Keystone DHP Topical Anesthetic Gel Recall: Defective Container Risk

Keystone Industries recalls DHP Topical Anesthetic Gel (Benzocaine 20%) due to potential incomplete seals in containers. This may lead to product leakage or contamination. Affected units have NDC 69634-020-30 and expire 04/15/2029.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0602-2026Drug Keystone Industries ›

Lower-risk recall

Defective container:may contain bottles with incomplete seals

Take action

Contact the company

Recalling firmKeystone Industries480 S Democrat Rd · Gibbstown, NJ 08027-1239

✎ GovInfoNow plain-language explainer

Keystone Industries is recalling DHP Topical Anesthetic Gel (Benzocaine 20%) because some containers may have incomplete seals. This could cause leakage or contamination, but the risk is low as the product is not intended for ingestion. Read more at govinfonow.com/recall/31291-keystone-dhp-topical-anesthetic-gel-recall-defective-container-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31291-keystone-dhp-topical-anesthetic-gel-recall-defective-container-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0602-2026

Cite this page

“Keystone DHP Topical Anesthetic Gel Recall: Defective Container Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31291-keystone-dhp-topical-anesthetic-gel-recall-defective-container-risk. Based on FDA recall #D-0602-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0602-2026%22&limit=1).

The FDA announced on May 21, 2026, that Keystone Industries is voluntarily recalling DHP Topical Anesthetic Gel due to defective containers that may have incomplete seals. The agency issued recall number D-0602-2026 for the ongoing Class II action.

How to tell if you have it

Brand: Keystone Industries
Product: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g)
Manufacturer/Distributor: Dental Health Products, Inc
NDC: 69634-020-30
Lot Code: BNZ-001921
Expiration Date: EXP 04/15/2029
Quantity: 150 units
Distribution: Nationwide in the USA

The hazard

The recall addresses a defective container issue where bottles may contain incomplete seals. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Keystone Industries has five other recalls on file since April 10, 2023. Recent brand actions include a November 14, 2024, recall of Dental City Anesthetic Gel for CGMP deviations and an October 17, 2024, recall of Perio Maintenance Rinse due to subpotent drug hazards. Other recent recalls of similar products include ANI Pharmaceuticals' Estradiol Gel recall (May 12, 2026), Sun Pharmaceutical's Diclofenac Gel recall (January 27, 2026), and Haleon's Gas-X Extra Strength Softgels recall (June 4, 2026).

How to tell if you have this one

Check for the product name 'DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor' with a 1 oz. (30 g) size. The NDC code is 69634-020-30 and it expires 04/15/2029.

Brand
Keystone Industries
Category
Drug

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	NDC
D-0600-2026	Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.; BNZ-001917, Exp 04/01/2029	900 units	43305-0009-3
D-0601-2026	Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.; BNZ-001921, EXP 04/15/2029	150 units	43128-034-30
D-0602-2026	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; BNZ-001921, EXP 04/15/2029	150 units	69634-020-30
D-0603-2026	Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30; BNZ-001917, Exp 04/15/2029	150 units	43498-310-30
D-0604-2026	Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30; BNZ-001921, Exp 04/15/2029	450 units	69483-001-30
D-0605-2026	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; BNZ-001921, EXP 04/15/2029	450 units	68987-001-30
D-0606-2026	safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.; BNZ-001921, Exp 04/15/2029	150 units	67239-0223-1

Based on the official FDA remedy

What to do — step by step

Check Container Seal
Inspect the container for signs of incomplete sealing, such as leaks or bulging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

May 21, 2026Firm started the recall
Jun 18, 2026FDA classified it Class II
Jun 24, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if I have the recalled product?

Look for the NDC code 69634-020-30 and expiration date 04/15/2029 on the container.

What should I do if I have the recalled product?

Inspect the container for incomplete seals. If you find any issues, stop using it and contact Keystone Industries for further guidance.

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Link to this recall

<a href="https://govinfonow.com/recall/31291-keystone-dhp-topical-anesthetic-gel-recall-defective-container-risk">Keystone DHP Topical Anesthetic Gel Recall: Defective Container Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0602-2026 (May 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0602-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.