PlainRecalls
LowClass IIITerminated

FDA Drug recall · Reported September 5, 2012

Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.

Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

Recall #
D-1671-2012
Affected scope
11,058 bottles
Initiated
July 27, 2012
Verify with FDA Drug →
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Natural Essentials Inc recalled Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle… - a low-severity action.

Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle… was recalled by Natural Essentials Inc in September 5, 2012. Reason: Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepa…. Check the official notice for the remedy. Verify recall #D-1671-2012 with the FDA Drug before acting.

The recall

Natural Essentials Inc issued this low-severity FDA Drug recall-Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepa….

Low
severity level
Class III
classification
September 5, 2012
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1671-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1671-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on July 27, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Natural Essentials Inc is listed as the recalling firm, operating out of Streetsboro, OH. Federal records list the affected scope as 11,058 bottles.

The documented reason for this recall is: Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,731 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 146
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

11,058 bottles

Related Recalls

6

0 from same agency

Product description

Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.

Reason for recall

Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-1671-2012
Date reported September 5, 2012
Date initiated July 27, 2012
Recalling firm Natural Essentials Inc
Firm location Streetsboro, OH
Affected scope 11,058 bottles
Distribution Nationwide

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-1671-2012) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.. Recalled by Natural Essentials Inc. Units affected: 11,058 bottles.
Why was this product recalled?
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 5, 2012. Severity: Low. Recall number: D-1671-2012.
Where was the recalled product distributed?
Distribution: Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1671-2012) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 5, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.