CLASS I Drug recall · Reported 9 Dec 2020 · FDA Enforcement Report
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free recalled
Lohxa is recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, distributed in Florida, New York. The recall was initiated on 28 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
Timeline
| 28 Oct 2020 | Recall initiated by company | |
| 30 Nov 2020 | Classified by FDA | +33 days |
| 9 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: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria 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
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
Where it was distributed
Product was distributed to medical facilities in FL and NY.
Questions about this recall
Why was it recalled?
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Which lots are affected?
Lot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021
Where was it sold?
Product was distributed to medical facilities in FL and NY.
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 Lohxa
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Senna Syrup (sennosides) 8.8 mg/ unit-dose cups recalled by Lohxa | Lohxa | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa | Lohxa | Other | MA, NY, WY |
| Drug | CLASS II | Bismuth Subsalicylate Oral Suspension 262mg/, unit dose cups recalled | Lohxa | Other | MA, NY, WY |
Other Chlorhexidine Gluconate Rinse recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorhexidine Gluconate Oral Rinse recalled by Precision Dose | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Chlorhexidine Gluconate Oral Rinse, 0.12% unit dose cups recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Chlorhexidine Gluconate Oral Rinse, 0.12% Unit Dose Cup recalled | Akorn | Potency & Assay | Nationwide |