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FDA recall record

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...

Recall H-0537-2026Class IIOngoingFebruary 3, 2026

FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.

Product described in an FDA recall

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)

Reason

Label declares bovine colostrum but does not declare milk allergen.

Products involved

Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.

  • 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)

Code information listed by FDA

LOT: 0528D911 Expiration Date: May 2028

Distribution and firm information

Recalling firm listed by FDA: Pure Solutions, Inc.

Firm location listed by FDA: Tampa, FL, United States

Distribution reported by FDA: 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

Product quantity listed by FDA: 442 units (bottles)

Source

Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.

Official FDA openFDA food enforcement record

Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.