Food recall

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

Pure Solutions, Inc., of Tampa, FL, recalled Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset. The FDA's reason: “Label declares bovine colostrum but does not declare milk allergen.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on February 3, 2026, and the FDA first listed it in its Enforcement Report of February 25, 2026. The recall is still going on.

How serious

Class II

It could cause temporary or minor harm

Why

Allergen not on the label

Status

Ongoing

The recall

Company
Pure Solutions, Inc. (Tampa, FL)
Reason, in FDA's words
“Label declares bovine colostrum but does not declare milk allergen.”
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
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
98413

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • H-0537-2026 Class II

    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)

    Codes: LOT: 0528D911 Expiration Date: May 2028

    Quantity: 442 units (bottles)

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of February 25, 2026.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.