Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by
Summary
The FDA issued a Class III for Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2 by Water-Jel Technologies, LLC. Reason: Failed PH Specifications.
Details
Source
Drug Recall
External ID
D-0509-2026
Action Date
2026-05-06
Status
Ongoing
Category
drug
Product Description
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Lot/Code Info: Lots: A5014, A5018, A5019
Quantity Affected: 31,488 tubes
Reason for Recall
Failed PH Specifications
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-07
Company
Huntersville, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Water-Jel Technologies, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Water-Jel Technologies, LLC have FDA actions?
This is the only FDA action we have on record for Water-Jel Technologies, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0509-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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