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.
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 3/5 (High).
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
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.
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
Same manufacturer · Keystone Industries
See all →- ModerateQuala Dental benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModeratePearson Quality benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModerateDHP benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModerateBurkhart benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModeratePureLife benzocaine topical anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
Same hazard · cgmp violation
See all →- Moderatevite20 Antifungal Cream recalled due to stability testing deviations
FDA (Drugs) · 2026-07-08
- ModerateNeuroquell products recalled over current good manufacturing practice violations
FDA (Drugs) · 2025-09-17
- ModerateOptim V Anti-Itch Cream Recalled for Current Good Manufacturing Practice Deviations
FDA (Drugs) · 2025-05-28
- ModerateNature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateRapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
Similar recalls
- ModerateCAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations
FDA (Drugs) · 2018-12-19
- ModeratePearson Quality benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- HighTopex Benzocaine Topical Anesthetic Recalled for Temperature-Abuse Manufacturing Deviation
FDA (Drugs) · 2022-06-15
- ModerateProfound Dental Gel Recalled for CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-02
- High
- ModerateProfound-PE Dental Gel Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02