Benzocaine Topical Gel Recalled Due to Manufacturing Quality Defect
Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 pharmaceutical recall due to CGMP deviation with potential contamination risk from manufacturing defect. No illnesses or injuries reported.
Plain-English summary
Keystone Industries is recalling Ipana 20% Benzocaine Topical Gel, 28g (Lot BNZ-001646, expiration 11/26/2026) due to a Current Good Manufacturing Practice (CGMP) deviation.
During routine inspection of the mixing vessel, the Quality Unit identified scratches on the sides and bottom of the vessel. The product should have been rejected but was inadvertently released and shipped to customers. The product was distributed nationwide in the United States and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar.
Benzocaine is a topical anesthetic. The scratched mixing vessel poses a potential quality and contamination risk. Consumers who have purchased this product should discontinue use and contact the manufacturer or their healthcare provider with questions.
The recalled product
- Product
- Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
- 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 No.: BNZ-001646
- Exp Date: 11/26/2026
- Keystone Item No. 03-35119
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.
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