Paroex — Class I drug recall D-0103-2021
Completed recall by Sunstar Americas, Inc., reported 2020-12-02, distributed nationwide. Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
| Recall number | D-0103-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Americas, Inc., Schaumburg, IL, United States |
| Recall initiated | 2020-10-27 |
| Classified | 2020-11-23 |
| Reported by FDA | 2020-12-02 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 52376-0021-02, 52376-0021-04 |
| Expiration dates | 2020-07-31, 2022-06-30, 2022-07-31, 2022-08-31, 2022-09-30 |
Product
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.
Reason for recall
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0103-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.