SparkleFresh Fluoride Toothpaste — Class II drug recall D-0247-2019
Terminated recall by Medline Industries Inc, reported 2018-11-14, distributed nationwide. Microbial Contamination of Non-Sterile Product
| Recall number | D-0247-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2018-09-17 |
| Classified | 2018-11-15 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 994,756 tubes |
| Reason classes | microbial contamination, sterility |
| NDC | 53329-0081-93, 53329-0083, 53329-0083-21, 53329-0083-92, 53329-0083-93, 53329-0083-94 |
| Lot numbers | 102920C, 111220C |
| Expiration dates | 2020-10-29, 2020-11-11, 2020-11-14, 2020-11-16, 2020-11-17 |
Product
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
Reason for recall
Microbial Contamination of Non-Sterile Product
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-0247-2019. 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.