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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 99125

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

Open FDA event record

Event summary

Timeline bucket
June 04, 2026
Product types
Drug
Classifications
Class I
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

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

D-0595-2026
Recall number
D-0595-2026
Initiated
June 04, 2026
Classification
Class I
Status
Ongoing
Recalling firm
Haleon US Holdings LLC
Quantity
35,883 boxes/carton

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Code information

Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.

Distribution pattern

Nationwide within the United States