Topical anesthetic gel recall due to manufacturing quality control deviation
Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.
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: FDA Class II recall for CGMP deviations with no reported illnesses or injuries. The hazard is procedural—the product was rejected for quality control reasons but was inadvertently shipped despite that determination.
Plain-English summary
Burkhart Topical Anesthetic Gel, Benzocaine 20%, manufactured by Keystone Industries, is being recalled due to manufacturing deviations discovered during routine quality control inspection. Scratches were observed on the sides and bottom of the mixing vessel used in product manufacturing, presenting a potential contamination risk.
The affected product (Lot: BNZ-001646, expiration date 11/26/2026) was flagged for rejection during quality inspection but was inadvertently released and shipped to customers. The product was distributed nationwide in the USA and Canada, as well as in the Dominican Republic, El Salvador, Honduras, and Qatar.
This is a Class II recall by the FDA. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical Anesthetic
- Hazard
- cgmp-deviation
- contamination-risk
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. 03-29119
Distribution
Distributed nationwide across the United States.
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