CLASS II Drug recall · Reported 25 Dec 2024 · FDA Enforcement Report
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content recalled
Keystone Industries is recalling Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content:, Gluten Free, distributed nationwide in the US. The recall was initiated on 14 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0139-2025
- FDA event ID
- 95854
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2024
- FDA classified
- 13 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 Nov 2024 | Recall initiated by company | |
| 13 Dec 2024 | Classified by FDA | +29 days |
| 25 Dec 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Questions about this recall
Why was it recalled?
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Which lots are affected?
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119
Where was it sold?
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 95854This product is part of a recall event; the main page for the event is Gelato, Benzocaine 20% Topical Gel Anesthetic Gel recalled.
More recalls from Keystone Industries
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |