Why it was 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.
Product description
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
Lot numbers, UPCs & expiration codes
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
Where it was sold
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0148-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2024
- FDA report date
- Dec 25, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Keystone Industries
Original FDA data
Every field from FDA enforcement report D-0148-2025, exactly as published.
Show all FDA fields
- City
- Gibbstown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 95854
- Address
- 480 S Democrat Rd
- Code information
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
- Postal code
- 08027-1239
- Report date
- Dec 25, 2024
- Product type
- Drugs
- Recall number
- D-0148-2025
- Classification
- Class II
- Recalling firm
- Keystone Industries
- Termination date
- Apr 23, 2026
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
- Distribution pattern
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Recall initiation date
- Nov 14, 2024
- Initial firm notification
- Center classification date
- Dec 13, 2024