Sunstar GUM Toothpaste 3 g tubes — Class II drug recall D-0997-2020
Terminated recall by Sunstar Guangzhou Ltd., reported 2020-03-18, distributed in FL. cGMP Deviation
| Recall number | D-0997-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Guangzhou Ltd., Guangzhou, China |
| Recall initiated | 2020-02-28 |
| Classified | 2020-03-09 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2021-03-29 |
| Distributed | FL |
| Quantity | 260,000 tubes |
| Reason classes | cgmp |
| NDC | 53050-0002-01 |
| Lot numbers | 20180621, 20180827, 20190115 |
| Expiration dates | 2020-06-21, 2020-08-27, 2021-01-15 |
Product
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Reason for recall
cGMP Deviation
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-0997-2020. 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.