CLASS II Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare recalled
Capco Custom Packaging is recalling Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral, distributed nationwide in the US. The recall was initiated on 27 Jul 2012 and the FDA has classified it as Class II.
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
- Recall number
- D-1664-2012
- FDA event ID
- 62756
- Recalling firm
- Capco Custom Packaging, Santa Fe Springs, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2012
- FDA classified
- 28 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 27 Jul 2012 | Recall initiated by company | |
| 28 Aug 2012 | Classified by FDA | +32 days |
| 5 Sep 2012 | Published in enforcement report | +8 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; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
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
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
Where it was distributed
Nationwide and Canada
Questions about this recall
Is Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral recalled?
Yes. Capco Custom Packaging recalled Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral on 27 Jul 2012. The recall is Class II and its status is Terminated. Recall number D-1664-2012.
Why was it recalled?
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Which lots are affected?
Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.
Where was it sold?
Nationwide and Canada
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.