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Lower risk Drug recall · FDA · Published November 14, 2024

Keystone Industries Gelato Anesthetic Gel Recall: CGMP Deviations

Keystone Industries recalls Gelato 20% Benzocaine Topical Gel due to CGMP deviations where mixing vessel scratches were found during routine inspection but product was inadvertently shipped.

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

🇺🇸 FDA recall #D-0137-2025DrugKeystone Industries ›
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Contact the company

Recalling firmKeystone Industries480 S Democrat Rd · Gibbstown, NJ 08027-1239
✎ GovInfoNow plain-language explainer

Keystone Industries is recalling Gelato 20% Benzocaine Topical Gel because quality control failed to catch scratches in the mixing vessel before shipping. This could lead to unsafe product if the gel is used without proper quality checks. Read more at govinfonow.com/recall/32426-keystone-industries-gelato-anesthetic-gel-recall-cgmp-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/32426-keystone-industries-gelato-anesthetic-gel-recall-cgmp-deviations · Updated August 17, 2026 · FDA enforcement record: FDA #D-0137-2025

Cite this page

“Keystone Industries Gelato Anesthetic Gel Recall: CGMP Deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32426-keystone-industries-gelato-anesthetic-gel-recall-cgmp-deviations. Based on FDA recall #D-0137-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0137-2025%22&limit=1).

The FDA announced on November 14, 2024, that Keystone Industries is recalling Gelato, Benzocaine 20% Topical Gel Anesthetic Gel due to current good manufacturing practice deviations. The bulk product was inadvertently released after the Quality Unit rejected it following a routine inspection.

How to tell if you have it

  • Brand: Keystone Industries
  • Product: Gelato, Benzocaine 20% Topical Gel Anesthetic Gel
  • Net Wt.: 1 oz. (30ml)
  • NDC#: 68400-352-30
  • Lot: BNZ-001646
  • Exp Date: 11/26/2026
  • Keystone item No.: 03-02319

The hazard

The hazard involves current good manufacturing practice deviations where the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom. The product was to be rejected but was inadvertently released and shipped to customers.

Context

GovInfoNow's records show Keystone Industries has 5 other recalls on record since April 10, 2023. Other recent recalls of similar products include Keystone Burkhart Anesthetic Gel Recall (May 21, 2026), Keystone Recalls Perio Maintenance Rinse Due to Subpotent Drug Hazard (October 17, 2024), and Keystone KeySplint Hard Clear: Wrong Instructions May Cause Misuse (November 20, 2023). Other recent recalls of similar products include Blossom Pharmaceuticals Globe Clotrimazole Cream Recall (October 31, 2025), Pro N: 5% Lidocaine Tattoo Numbing Spray Recall (February 2, 2026), and Blossom Globe Clotrimazole Cream Recall (October 31, 2025).

How to tell if you have this one

Check for the product name 'Gelato, Benzocaine 20% Topical Gel Anesthetic Gel', net weight 1 oz. (30ml), manufactured by Keystone Industries at 480 S. Democrat Rd., Gibbstown, NJ 08027. Lot number BNZ-001646 with expiration date 11/26/2026.

  • Brand
    Keystone Industries
  • Category
    Drug
FDA recall event · 12 products

All 12 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
    Terminated
  • Distribution
    Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Recall numberProduct, codes & lotsQuantityNDC
D-0137-2025Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone item No. 03-02319—68400-352-30
D-0138-2025M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No: 03-09619——
D-0139-2025Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119——
D-0140-2025Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-25119——
D-0141-2025Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-27119—50227-1002-3
D-0142-2025Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-28119—69634-021-30
D-0143-2025Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-29119——
D-0144-2025Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-30619——
D-0145-2025safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119—67239-0219-1
D-0146-2025Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com; Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419——
D-0147-2025Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.; Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-35119——
D-0148-2025Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,; Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619——
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, net weight, manufacturer location, lot number, and expiration date to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Nov 14, 202412. FDA classified it Class II: Dec 13, 202423. Published in FDA’s Enforcement Report: Dec 25, 202434. FDA terminated the recall: Apr 23, 2026420242026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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Keep exploring

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-0137-2025 (November 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0137-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA