Recall Ledger

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset recall (Pure Solutions, Inc.)

FoodClass IIOngoing

Summary: Pure Solutions, Inc. is recalling 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.

What is being recalled

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)

Why

Label declares bovine colostrum but does not declare milk allergen.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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 (states named: Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming)

How to tell if yours is affected

LOT: 0528D911 Expiration Date: May 2028

What to do

Check the product name and the codes above against what you have. If they match, do not eat or use it. Throw it away or return it to the store where you bought it, and contact the recalling company with questions.

Recall facts

Recall numberH-0537-2026
CategoryFood
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedFebruary 3, 2026
ReportedFebruary 25, 2026
CompanyPure Solutions, Inc.
Company locationTampa, FL, United States
Initiated byVoluntary: Firm initiated
Quantity442 units (bottles)

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Official FDA record