The Recall Desk
ModerateFDA (Drugs)·D-0148-2025·Announced 2024-12-25

FDA Recalls Benzo-Jel Topical Anesthetic Gel Due to Manufacturing Defect

Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing quality-control deviation (vessel scratches) detected during inspection; the product was recalled precautionarily.

Plain-English summary

Keystone Industries is recalling Henry Schein Benzo-Jel, a 20% benzocaine topical anesthetic gel (lot BNZ-001646, expiration 11/26/2026) due to manufacturing quality deviations.

During routine inspection of the mixing vessel, scratches were discovered on the sides and bottom of the equipment. The product was flagged for rejection by the Quality Unit but was inadvertently released and shipped to customers.

The product was distributed nationwide in the USA and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar. The product is labeled "For Professional Use Only."

The recalled product

Product
Henry 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,
Manufacturer
Keystone Industries
Category
Drug — Topical Anesthetic
Hazard
  • manufacturing-defect
  • foreign-material

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot: BNZ-001646
  • Exp Date: 11/26/2026
  • Keystone Item No. 03-43619

Distribution

Distributed nationwide across the United States.

Related recalls

Same category