Topical Anesthetic Gel Recalled for Manufacturing Process Deviation
Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released 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 for manufacturing process deviation with no reported illnesses or injuries. The hazard is theoretical (potential contamination from equipment damage) rather than confirmed product contamination.
Plain-English summary
Safco SensiCaine Ultra Topical Anesthetic Gel (20% Benzocaine, 1 oz) manufactured by Keystone Industries and distributed by Safco Dental Supply Co. is being recalled. This topical anesthetic is intended for professional dental use only.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. During routine quality control inspection, scratches were identified on the sides and bottom of the mixing vessel used to produce the bulk product. The affected product was designated for rejection and destruction, but was inadvertently released and shipped to customers.
Lot BNZ-001646 with an expiration date of November 26, 2026, was distributed nationwide in the United States and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar. The FDA has classified this as a Class II recall.
The recalled product
- Product
- SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL (BENZOCAINE)
- Brand
- SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical Anesthetic
- Hazard
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. 03-64119
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.
See all 12 products in this recall →Related recalls
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