Chlorhexidine Gluconate Oral Rinse USP — Class I drug recall D-0111-2021
Terminated recall by Lohxa LLC, reported 2020-12-09, distributed in FL, NY. Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it wa
| Recall number | D-0111-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lohxa LLC, Worcester, MA, United States |
| Recall initiated | 2020-10-28 |
| Classified | 2020-11-30 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-03-15 |
| Distributed | FL, NY |
| Quantity | 329 cartons |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 70166-0027-15 |
| Lot numbers | M10193A, T08292A, T09101A, T10011A, T10223A |
| Expiration dates | 2021-01, 2021-02, 2021-03 |
Product
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15
Reason for recall
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria 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-0111-2021. 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.