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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98198

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

Open FDA event record

Event summary

Timeline bucket
December 26, 2025
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Haleon US Holdings LLC

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

parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02

D-0297-2026
Recall number
D-0297-2026
Initiated
December 26, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Haleon US Holdings LLC
Quantity
84,764 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

Code information

Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.

Distribution pattern

Nationwide in the USA