FDA Recall of Lidocaine Wound Gel Due to Failed pH Specifications

Source: FDA · United States

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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.