RecallRadar

FDA Drug recall D-0111-2021

Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count un…

On 2020-12-09 the FDA classified a Class I recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count un… by Lohxa, citing microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0111-2021
ClassificationClass I
Statusterminated
Initiated2020-10-28
Published2020-12-09
Last updated2026-09-13 11:52 UTC
CompanyLohxa
DistributionFL, NY

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

Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Identifiers

code_infoLot #: T09101A, Exp 01/2021; T08292A, T10011A, Exp 02/2021; T10223A, M10193A, Exp 03/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0111-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.