CLASS III Drug recall · Reported 4 Apr 2018 · FDA Enforcement Report
Chlorhexidine Gluconate Oral Rinse, 0.12% unit dose cups recalled
Akorn is recalling Chlorhexidine Gluconate Oral Rinse, 0.12% unit dose cups (, distributed nationwide in the US. The recall was initiated on 29 Mar 2018 and the FDA has classified it as Class III.
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-0611-2018
- FDA event ID
- 79635
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Mar 2018
- FDA classified
- 29 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 Mar 2018 | Recall initiated by company | |
| 29 Mar 2018 | Classified by FDA | +0 days |
| 4 Apr 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
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%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Which lots are affected?
Lot #: 350836, Exp 05/18
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 79635This product is part of a recall event; the main page for the event is 24-HOUR Oral Care q2 Kit with Ballard* Technology recalled by Akorn.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | 24-HOUR Oral Care q2 Kit with Ballard* Technology recalled by Akorn | Akorn | Potency & Assay | Nationwide | |
| CLASS III | 24-HOUR Oral Care q4 Kit with Ballard* Technology 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 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 I | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free recalled | Lohxa | Sterility | FL, NY |
| Drug | CLASS III | Chlorhexidine Gluconate Oral Rinse, 0.12% Unit Dose Cup recalled | Akorn | Potency & Assay | Nationwide |