Benzocaine Topical Anesthetic Recalled for Manufacturing Equipment Defect
Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall driven by a manufacturing quality control deviation (equipment damage) rather than confirmed product contamination or reported illnesses. The hazard is potential rather than demonstrated, fitting the category of precautionary recalls due to manufacturing defects.
Plain-English summary
Keystone Industries is recalling Gelato Benzocaine 20% Topical Gel Anesthetic, Net Wt. 1 oz. (30ml), NDC# 68400-352-30, Lot BNZ-001646, with expiration date 11/26/2026. This is an over-the-counter topical anesthetic gel used for dental and oral applications.
During routine manufacturing inspection, the Quality Unit identified scratches on the sides and bottom of the mixing vessel used to produce this lot. The defective product was rejected by the Quality Unit but was inadvertently released and shipped to customers despite the rejection decision. This represents a deviation from Current Good Manufacturing Practice (CGMP) standards.
The product was distributed nationwide in the United States and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar. Consumers and healthcare providers who received this lot should stop using the product.
Consumers and healthcare providers with this product should discontinue use, contact Keystone Industries for return instructions, or consult their healthcare provider or pharmacist for questions.
The recalled product
- Product
- GELATO TOPICAL ANESTHETIC (BENZOCAINE)
- Brand
- GELATO TOPICAL ANESTHETIC
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical / Anesthetic
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. 03-02319
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 · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-09
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12