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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98413

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

Open FDA event record

Event summary

Timeline bucket
February 03, 2026
Product types
Food
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Pure Solutions, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Food 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.

food · product 1 of 1

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sold in case lots)

H-0537-2026
Recall number
H-0537-2026
Initiated
February 03, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Pure Solutions, Inc.
Quantity
442 units (bottles)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Label declares bovine colostrum but does not declare

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Label declares bovine colostrum but does not declare milk allergen.

Code information

LOT: 0528D911 Expiration Date: May 2028

Distribution pattern

Product was distributed to: AR, FL, CO, CA, CT, HI, IN, IL, ID, IA, KS, KY, LA, OH, OK, OR, MA, MI, MN, MO, GA, NC, NE, ND, NY, PA, SC, TN, NJ, UT, TX, VA , WA, WV, WI, WY

Field note

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