Has Keystone Industries had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to Keystone Industries, including 7 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Class II Recall: SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL by Keystone Industries

Key facts

Recalling firm	Keystone Industries
Manufacturer	Safco Dental Supply Co.
Brand name	SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL
Product description	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.
Classification	Class II
Recall number	D-0606-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Defective container:may contain bottles with incomplete seals

In short: Keystone Industries recalled 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. on 2026-06-24. FDA classified this action as a Class II recall (recall number D-0606-2026). Reason for recall: Defective container:may contain bottles with incomplete seals. Recall status: Ongoing. This is a drug-category FDA recall record.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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. -- and the recall number D-0606-2026. If it matches, stop using or distributing it and contact Keystone Industries or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Keystone Industries and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: Defective container:may contain bottles with incomplete seals. The recall is tracked under FDA recall number D-0606-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Keystone Industries’s FDA history

Argus HQ has recorded 7 total FDA actions tied to Keystone Industries: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Keystone Industries had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to Keystone Industries, including 7 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number D-0606-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for Keystone Industries

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL by Keystone Industries. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-keystone-industries-d-0606-2026

MLA

"FDA Class II Recall: SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL by Keystone Industries." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-keystone-industries-d-0606-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL by Keystone Industries." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-keystone-industries-d-0606-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_keystone_industries_d_0606_2026_2026,
  title = {FDA Class II Recall: SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL by Keystone Industries},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-keystone-industries-d-0606-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗