Chlorhexidine Gluconate Oral Rinse USP 0 — Class II drug recall D-0228-2021
Terminated recall by Precision Dose Inc., reported 2021-01-20, distributed nationwide. cGMP deviations: The firm was notified of the manufacturer's expanded recall.
| Recall number | D-0228-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Dose Inc., South Beloit, IL, United States |
| Recall initiated | 2021-01-01 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2024-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,107,510 units |
| Reason classes | cgmp |
| NDC | 68094-0028-61, 68094-0028-62 |
| Expiration dates | 2021-01-31, 2021-08-31, 2021-09-30, 2021-10-31, 2021-11-30, 2021-12-31, 2022-02-28 |
Product
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.
Reason for recall
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0228-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.