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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76516

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 13, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Colgate Palmolive Co

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0521-2017
Recall number
D-0521-2017
Initiated
February 13, 2017
Classification
Class III
Status
Terminated
Recalling firm
Colgate Palmolive Co
Quantity
14,656 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.

Code information

Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G

Distribution pattern

Nationwide