Canker-X Rincinol Mouth Sore Rinse Lot CodeRecalls & reported problems
Alliance Pharma Inc. · Canker-X Rincinol Mouth Sore Rinse 120ml · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00358962302008), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burning Sensation1
- Glossitis1
- Hypersensitivity/Allergic reaction1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
A 72-YEAR-OLD CONSUMER REPORTED A SEVERE ORAL ADVERSE REACTION FOLLOWING A SINGLE USE OF CANKER-X RINCINOL MOUTH SORE RINSE. THE CONSUMER STATED THEY FOLLOWED THE INSTRUCTIONS TO SWISH FOR ONE MINUTE AND SPIT. IMMEDIATELY UPON USE, THE CONSUMER EXPERIENCED INTENSE BURNING OF THE TONGUE, GUMS, AND ORAL MUCOSA, WITH ASSOCIATED TOOTH PAIN AND DIFFICULTY SPEAKING. THE CONSUMER DESCRIBED THE ONSET AS INSTANTANEOUS AND CLEARLY LINKED IT TO PRODUCT USE. SYMPTOMS PERSISTED THROUGHOUT THE FOLLOWING 2-3 WEEKS. THE CONSUMER REPORTED SIGNIFICANT FUNCTIONAL LIMITATIONS, INCLUDING PAIN WITH SPEAKING, CHEWING, AND SWALLOWING, AND WAS ABLE TO TOLERATE ONLY SOFT FOODS SUCH AS OATMEAL AND SOUP. THE BURNING SENSATION WAS REPORTED TO BE UNCHANGED DESPITE RINSING WITH WATER AND USING PRESCRIBED TREATMENTS. THE CONSUMER SOUGHT REPEATED MEDICAL EVALUATION, INCLUDING MULTIPLE EMERGENCY DEPARTMENT VISITS, AN AMBULANCE TRANSPORT FOR TONGUE SWELLING AND DIFFICULTY SWALLOWING, AND EVALUATIONS BY AN INFECTIOUS DISEASE SPECIALIST, AN ORAL AND MAXILLOFACIAL SURGEON, AND OTHER PHYSICIANS. ACCORDING TO THE CONSUMER, EXTENSIVE LABORATORY TESTING WAS PERFORMED TO INVESTIGATE POTENTIAL INFECTIOUS, INFLAMMATORY, AUTOI
Patient problems: Burning Sensation; Glossitis; Hypersensitivity/Allergic reaction; Pain
MAUDE report 24778301 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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