CLASS I Drug recall · Reported 2 Dec 2020 · FDA Enforcement Report
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free recalled
Sunstar Americas is recalling Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, distributed nationwide in the US. The recall was initiated on 27 Oct 2020 and the FDA has classified it as Class I.
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-0103-2021
- FDA event ID
- 86656
- Recalling firm
- Sunstar Americas, Schaumburg, IL
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 27 Oct 2020
- FDA classified
- 23 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 27 Oct 2020 | Recall initiated by company | |
| 23 Nov 2020 | Classified by FDA | +27 days |
| 2 Dec 2020 | 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: contamination with Burkholderia lata.
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
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Which lots are affected?
Lot #: a) 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; b) C191KR, Exp 7/31/2020
Where was it sold?
USA 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Sunstar Americas
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Butler Clear Dip/case recalled by Sunstar Americas | Sunstar Americas | Other | Nationwide |
| Device | CLASS II | Sunstar G.U.M Perioshield Oral Health Rinse recalled by Sunstar Americas | Sunstar Americas | Sterility | Nationwide |
| Device | CLASS II | Sunstar Butler Clear Dip recalled by Sunstar Americas | Sunstar Americas | Sterility | IL |
| Device | CLASS II | Sunstar G.u.m recalled by Sunstar Americas | Sunstar Americas | Sterility | Nationwide |
| Drug | CLASS II | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free recalled | Sunstar Americas | Sterility | Nationwide |
Other Paroex (chlorhexidine Gluconate) Rinse recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free recalled | Sunstar Americas | Sterility | Nationwide |