FDA Recall D-0509-2026
Water-Jel Technologies, LLC · Huntersville, NC
Class III Ongoing 37 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed PH Specifications
Recall record
- Recall number
D-0509-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2026-04-07
- Classified by FDA Center
- 2026-04-30
- FDA published
- 2026-05-06
- Recalling firm
- Water-Jel Technologies, LLC
- Firm location
- Huntersville, NC
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.