Primo Topical Anesthetic Gel Recalled for Manufacturing Defect
Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.
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 with no reported illnesses or injuries. The manufacturing defect (scratches in mixing vessel) creates potential contamination risk, qualifying as a risk-of-harm product without yet-reported injury per the High severity criterion.
Plain-English summary
Primo Topical Anesthetic Gel (Benzocaine 20%), manufactured by Keystone Industries for Primo Dental Products, is being recalled due to current good manufacturing practice (CGMP) deviations.
During routine inspection of the manufacturing process, a Quality Unit identified scratches on the interior sides and bottom of the mixing vessel used to prepare the product. The affected lot was to be rejected but was inadvertently released and shipped to customers. The scratches in the vessel present a potential source of contamination.
This recall affects product distributed nationwide in the United States and Canada, as well as the Dominican Republic, El Salvador, Honduras, and Qatar. The recalled lot is BNZ-001646 with an expiration date of November 26, 2026 (Keystone Item No. 03-13119).
Consumers should discontinue use of this product and contact their healthcare provider or the manufacturer with any questions. Product should be safely discarded or returned according to the manufacturer's instructions.
The recalled product
- Product
- Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
- Manufacturer
- Keystone Industries
- Hazard
- cgmp-violation
- manufacturing-defect
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. 03-13119
Distribution
Distributed nationwide across the United States.
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