CLASS II Drug recall · Reported 20 Jan 2021 · FDA Enforcement Report
Chlorhexidine Gluconate Oral Rinse recalled by Precision Dose
Precision Dose is recalling Chlorhexidine Gluconate Oral Rinse USP 0.12%, distributed nationwide in the US. The recall was initiated on 1 Jan 2021 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-0228-2021
- FDA event ID
- 87081
- Recalling firm
- Precision Dose, South Beloit, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jan 2021
- FDA classified
- 14 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 1 Jan 2021 | Recall initiated by company | |
| 14 Jan 2021 | Classified by FDA | +13 days |
| 20 Jan 2021 | 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
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Product as listed by the FDA
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Which lots are affected?
Lot #: a) 502037, 502040, 502043, Exp 1/31/2021; 502494, 502757, Exp 8/31/2021; 502677, Exp 9/30/2021; 502693, 502728, Exp 10/31/2021; 502771, 502784, Exp 11/30/2021; 502824, Exp 12/31/2021; 502925, Exp 2/28/2022; b) 502037, 502040, 502043, Exp 1/31/2021; 502494, Exp 8/31/2021; 502759, Exp 10/31/2021; 502771, Exp 11/30/2021
Where was it sold?
Nationwide 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 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.
More recalls from Precision Dose
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 160 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 325 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Carbamazepine Oral Suspension USP, 100 mg/ Unit Dose Cups recalled | Precision Dose | Potency & Assay | Nationwide |
Other Chlorhexidine Gluconate Rinse recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 cups recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Chlorhexidine Gluconate Oral Rinse, 0.12% Unit Dose Cup recalled | Akorn | Potency & Assay | Nationwide |