FDA Drug recall D-0875-2016

Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC.…

FDA Drug
Class II
terminated
Published 2016-06-01

On 2016-06-01 the FDA classified a Class II recall of Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC.… by Akorn, citing failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0875-2016
Classification	Class II
Status	terminated
Initiated	2016-03-23
Published	2016-06-01
Last updated	2026-09-13 11:51 UTC
Company	Akorn
Distribution	US

Product

Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16

Reason

Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

Identifiers

code_info	Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148,… Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148, 628151, 628230, 628232, 628365, Exp 6/16; 628589 , 628592, 628598, 628802, 628805, 628808, 628811, 628814, Exp 7/16 ; 629059, 629204, 629207, 629232, 629235, 629307, 629310, 629313, 629316, Exp 8/16; 629687, 629693, 629696, 629882, 629888, 630058, Exp 9/16; 630061, 630064, 630221, 630224, 630362, 630365, 630613, Exp 10/16; 630615, 630732, 630735, 630853, 630856, 630859, 631008, Exp 11/16; 631026, 631027, 631169, 631172, 631175, 631655, 631658, Exp 12/16; 631704, 631707, 631861, 631864, 631867, 632059, 632062, 632065, 632068, 632071, 632074, 632211, 632214 Exp 1/17; 632328, 632331, 632334, 632337, 632472, 632475, 632504, 632507, 632697, Exp 2/17; 633090, 633093, 632776, 632781, 632784, 632790, 632793, 632796, 632805, 632808, 632811, 632814, 633072, 633078, 633081, 633084, 633087, Exp 3/17; 633681, 633682, 633099, 633684, 633111, Exp 4/17; 345607, 345618, 345620, Exp 5/

code_info

Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148,…

Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148, 628151, 628230, 628232, 628365, Exp 6/16; 628589 , 628592, 628598, 628802, 628805, 628808, 628811, 628814, Exp 7/16 ; 629059, 629204, 629207, 629232, 629235, 629307, 629310, 629313, 629316, Exp 8/16; 629687, 629693, 629696, 629882, 629888, 630058, Exp 9/16; 630061, 630064, 630221, 630224, 630362, 630365, 630613, Exp 10/16; 630615, 630732, 630735, 630853, 630856, 630859, 631008, Exp 11/16; 631026, 631027, 631169, 631172, 631175, 631655, 631658, Exp 12/16; 631704, 631707, 631861, 631864, 631867, 632059, 632062, 632065, 632068, 632071, 632074, 632211, 632214 Exp 1/17; 632328, 632331, 632334, 632337, 632472, 632475, 632504, 632507, 632697, Exp 2/17; 633090, 633093, 632776, 632781, 632784, 632790, 632793, 632796, 632805, 632808, 632811, 632814, 633072, 633078, 633081, 633084, 633087, Exp 3/17; 633681, 633682, 633099, 633684, 633111, Exp 4/17; 345607, 345618, 345620, Exp 5/

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0875-2016%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.