# FDA recall D-0521-2017

> **Colgate Palmolive Co** · Class III · drug recall initiated 2017-02-13.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0521-2017
- **Recalling firm:** Colgate Palmolive Co
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-13
- **Report date:** 2017-03-22
- **Termination date:** 2017-06-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0521-2017

## Citation

> AI Analytics. FDA recall D-0521-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0521-2017. Source: US FDA. Licensed CC0.

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