CLASS III Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
Alcohol Free Antiseptic (cetylpyridinium chloride) Mouth recalled
Vi-Jon is recalling Alcohol Free Antiseptic (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, distributed nationwide in the US. The recall was initiated on 18 Jul 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Timeline
| 18 Jul 2013 | Recall initiated by company | |
| 22 Jul 2013 | Classified by FDA | +4 days |
| 31 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
Where it was distributed
Nationwide
Stores named: Kroger
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Which lots are affected?
Lot #: 0185828, Exp 12/14
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vi-Jon
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Kroger Mint Burst Antiseptic Mouth Rinse recalled by Vi-Jon | Vi-Jon | Labeling Errors | TN |
| Drug | CLASS I | equate Magnesium Citrate, Saline Laxative/fl oz), Grape Flavor recalled | Vi-Jon | Sterility | Nationwide |
| Drug | CLASS I | Equaline magnesium citrate saline laxative recalled by Vi-JonCitroma | Vi-Jon | Sterility | Nationwide |
| Drug | CLASS I | Topcare health, Magnesium Citrate, Saline Laxative recalled by Vi-JonCitroma | Vi-Jon | Sterility | Nationwide |
| Drug | CLASS I | Walgreens, Dye-Free, Magnesium Citrate, Saline Laxative recalled | Vi-Jon | Sterility | Nationwide |