FDA Drug recall D-0103-2021

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02

FDA Drug
Class I
completed
Published 2020-12-02

On 2020-12-02 the FDA classified a Class I recall of Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02 by Sunstar Americas, citing microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0103-2021
Classification	Class I
Status	completed
Initiated	2020-10-27
Published	2020-12-02
Last updated	2026-09-13 11:52 UTC
Company	Sunstar Americas
Distribution	US

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

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Identifiers

code_info	Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW… 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

code_info

Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW…

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

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0103-2021%22

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