CLASS II Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Chlorhexidine gluconate, oral rinse recalled by Akorn
Akorn is recalling Chlorhexidine gluconate, oral rinse, 0.12%, distributed nationwide in the US. The recall was initiated on 23 Mar 2016 and the FDA has classified it as Class II.
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
- Recall number
- D-0875-2016
- FDA event ID
- 73491
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2016
- FDA classified
- 25 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Mar 2016 | Recall initiated by company | |
| 25 May 2016 | Classified by FDA | +63 days |
| 1 Jun 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Which lots are affected?
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 5/17; 346575, 346863, 346571, 346720,3 46573, Exp 7/17
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
2 other products · FDA event 73491| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PerioRx (chlorhexidine gluconate), oral rinse recalled by Akorn | Akorn | Potency & Assay | Nationwide | |
| CLASS II | ORIS (chlorhexidine gluconate), oral rinse recalled by Akorn | Akorn | Potency & Assay | Nationwide |
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Chlorhexidine Gluconate recalls
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Other | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |