Pure Solutions, Inc. recall: Pure Factors Professional Nighttime Sleep Formula and Pure

The record

Firm

Pure Solutions, Inc., Tampa, FL

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)

Reason, as filed

“Label declares bovine colostrum but does not declare milk allergen.”

Classification

Class II (Class II: may cause temporary or medically reversible harm)

Recall number

H-0537-2026

Initiated

February 3, 2026

Posted by FDA

February 25, 2026

Status

Ongoing · Voluntary: Firm initiated

Quantity

442 units (bottles)

Distribution

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

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