Unrated Drug recall · FDA · Published October 27, 2020

Sunstar Paroex Oral Rinse Recall: Microbial Contamination Risk

Sunstar recalls Paroex (chlorhexidine gluconate) oral rinse due to Burkholderia lata contamination. This prescription rinse may cause infection if used. Consumers should contact Sunstar for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0103-2021Drug Sunstar ›

Recall notice

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Take action

Contact the company

Recalling firmSunstar Americas, Inc.301 E Central Rd · Schaumburg, IL 60195-1901

✎ GovInfoNow plain-language explainer

Sunstar is recalling Paroex oral rinse products that may contain Burkholderia lata bacteria. Using these products could lead to infections, especially since they are prescription-only and intended for oral use. Read more at govinfonow.com/recall/36696-sunstar-paroex-oral-rinse-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36696-sunstar-paroex-oral-rinse-recall-microbial-contamination-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0103-2021

Cite this page

“Sunstar Paroex Oral Rinse Recall: Microbial Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36696-sunstar-paroex-oral-rinse-recall-microbial-contamination-risk. Based on FDA recall #D-0103-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0103-2021%22&limit=1).

The FDA announced on Oct. 27, 2020, that Sunstar Americas, Inc. is recalling Paroex Oral Rinse due to microbial contamination with Burkholderia lata. The agency issued recall number D-0103-2021 for the voluntary Class I action.

How to tell if you have it

Brand: Sunstar
Product: Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only
Sizes: 1 pint (473 mL) NDC 52376-021-02; 4 fl oz (118 mL) NDC 52376-021-04
Lot codes (1 pint): C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR (Exp 6/30/2022); C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN (Exp 7/31/2022); C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS (Exp 8/31/2022); C240GM, C240GP, C240GQ, C240GR (Exp 9/30/2022)
Lot codes (4 fl oz): C191KR (Exp 7/31/2020)
Distribution: USA Nationwide

The hazard

According to the FDA, the Paroex Oral Rinse products are contaminated with Burkholderia lata. The agency classified this as a Class I recall, indicating a high risk of adverse health consequences.

Context

GovInfoNow's records show Sunstar Americas, Inc. has five other recalls on record since Dec. 28, 2020. Other recent recalls of similar products include Sunstar Perioshield Oral Rinse Recall (May 21, 2021) and Sunstar Butler Clear Dip Recall (March 23, 2021). Additional microbial contamination risks were reported in Walgreens Saline Nasal Spray with Xylitol Recall (Nov. 12, 2025), Medinatura ReBoost Nasal Spray Recall (Dec. 12, 2025), and Beekeeper's Naturals Saline Nasal Spray Recall (June 1, 2026).

How to tell if you have this one

Check the product label for the specific lot numbers listed: C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, C240GM, C240GP, C240GQ, C240GR. The products were sold in 1 pint (473 mL) and 4 fl oz (118 mL) sizes.

Brand
Sunstar
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the specific lot numbers listed in the recall to determine if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

Oct 27, 2020Firm started the recall
Nov 23, 2020FDA classified it Class I
Dec 2, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36696-sunstar-paroex-oral-rinse-recall-microbial-contamination-risk">Sunstar Paroex Oral Rinse Recall: Microbial Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0103-2021 (October 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0103-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.