PreviDent 5000 ppm — Class III drug recall D-0521-2017
Terminated recall by Colgate Palmolive Co, reported 2017-03-22, distributed nationwide. Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
| Recall number | D-0521-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Colgate Palmolive Co, New York, NY, United States |
| Recall initiated | 2017-02-13 |
| Classified | 2017-03-15 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 14,656 bottles |
| Reason classes | labeling |
| NDC | 00126-0016, 00126-0016-61 |
| Lot numbers | 6350US561G, 6350US562G, 6351US561G, 6351US562G |
Product
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
Reason for recall
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
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-0521-2017. 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.