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Recall Observatory FDA recall evidence

Food product

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

February 03, 2026

Class II

Product summary

Firm
Pure Solutions, Inc.
Event
Event 98413
Status
Ongoing
Classification
Class II
Quantity
442 units (bottles)
Official record key
food-enforcement:H-0537-2026

Official wording

Reason: 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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Label declares bovine colostrum but does not declare