Why it was recalled
Defective container:may contain bottles with incomplete seals
Product description
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Lot numbers, UPCs & expiration codes
BNZ-001921, EXP 04/15/2029
Where it was sold
Nationwide in the USA
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-0601-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 21, 2026
- FDA report date
- Jun 24, 2026
- Quantity
- 150 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Keystone Industries
Original FDA data
Every field from FDA enforcement report D-0601-2026, exactly as published.
Show all FDA fields
- City
- Gibbstown
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99076
- Address
- 480 S Democrat Rd
- Code information
- BNZ-001921, EXP 04/15/2029
- Postal code
- 08027-1239
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0601-2026
- Classification
- Class II
- Recalling firm
- Keystone Industries
- Product quantity
- 150 units
- Reason for recall
- Defective container:may contain bottles with incomplete seals
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 21, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2026