April 2026 FDA Recall Drug by Water-jel Technologies, Llc
D-0509-2026 - Failed PH Specifications

This Class III drug recall was voluntarily initiated by Water-jel Technologies, Llc on April 7, 2026 for the product Drug. The FDA reported the reason for recall as failed ph specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0509-2026

Reason for Recall
Failed PH Specifications
Initiated
04-07-2026
Reported
05-06-2026
Quantity
31,488 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98737
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Water-Jel Technologies, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lots: A5014, A5018, A5019