Lidocaine Wound Gel (Benzalkonium Chloride recall
FDA recall D-0509-2026 · initiated Apr 7, 2026
Water-Jel Technologies, LLC recalled Lidocaine Wound Gel (Benzalkonium Chloride in Apr 2026 — an FDA Class III recall (D-0509-2026) because Failed PH Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed PH Specifications
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 31,488 tubes
Details
- Product
- 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
- Recalling company
- Water-Jel Technologies, LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 7, 2026
- FDA report date
- May 6, 2026
Frequently asked
- Was Lidocaine Wound Gel (Benzalkonium Chloride recalled?
- Water-Jel Technologies, LLC recalled Lidocaine Wound Gel (Benzalkonium Chloride in Apr 2026 — an FDA Class III recall (D-0509-2026) because Failed PH Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Lidocaine Wound Gel (Benzalkonium Chloride recalled?
- Per the FDA enforcement record, the reason for recall D-0509-2026 was: Failed PH Specifications
- Is a recalled Lidocaine Wound Gel (Benzalkonium Chloride dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lidocaine Wound Gel (Benzalkonium Chloride are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots: A5014, A5018, A5019. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0509-2026.