FDA Recall of Lidocaine Wound Gel Due to Failed pH Specifications
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Water-Jel Technologies, LLC is recalling 31,488 tubes of Lidocaine Wound Gel because they failed pH specifications, affecting products distributed nationwide in the US.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Water-Jel Technologies, LLC is recalling certain lots of Lidocaine Wound Gel due to failed pH specifications. This is a voluntary recall initiated by the firm.
Which Products Are Affected
The affected product is Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), with NDC 59898-950. A total of 31,488 tubes are involved, specifically lots A5014, A5018, and A5019. These products were distributed nationwide in the United States.
What You Should Do
Consumers who have the affected product should check the lot numbers and contact Water-Jel Technologies, LLC at their address: 13359 Reese Blvd East, Huntersville, NC 28078, as the recall was initiated via letter.
Why This Matters
This recall highlights potential quality issues in pharmaceutical products, which could impact their effectiveness, though it is classified as a Class III recall indicating a low risk to public health.
Source
This information is from the FDA recall notice with recall number D-0509-2026. For more details, refer to the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,093 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.