FDA Recalls Health-Tec Benzocaine Topical Anesthetic Due to Manufacturing Defect
Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing defect in dental anesthetic. Scratches in mixing vessel create potential contamination risk. Hazard is theoretical with no confirmed contamination or reported illnesses, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Keystone Industries is recalling one lot of Health-Tec Topical Anesthetic (Benzocaine 20%), a dental topical anesthetic, due to manufacturing defects identified during quality inspection. The affected lot is BNZ-001646, with expiration date 11/26/2026 (NDC 69634-021-30, 1 FL. OZ / 29.6 ml).
The recall was initiated following discovery of Current Good Manufacturing Practice (CGMP) deviations. During routine inspection of the mixing vessel, scratches were found on the sides and bottom of the vessel. Although the product was designated for rejection due to these defects, it was inadvertently released from the manufacturing facility and shipped to customers.
The affected product was distributed nationwide in the United States and Canada, as well as internationally in the Dominican Republic, El Salvador, Honduras, and Qatar.
The recalled product
- Product
- HEALTH-TEC TOPICAL ANESTHETIC (BENZOCAINE)
- Brand
- HEALTH-TEC TOPICAL ANESTHETIC
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical Anesthetic
- Hazard
- contamination-risk
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. 03-28119
Distribution
Distributed nationwide across the United States.
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