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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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.
Part of a larger recall action
This product is one of 12 recalled by Keystone Industries under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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