FDA Drug recall D-0521-2017
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL),…
- FDA Drug
- Class III
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class III recall of PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL),… by Colgate Palmolive, citing label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0521-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-02-13 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Colgate Palmolive |
| Distribution | US |
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
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Identifiers
| ndc | 0126-0016-61 |
|---|---|
| ndc | 3834110622 |
| code_info | Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0521-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.