Recall Radar

Pure Solutions recalls Pure Factors Professional Nighttime Sleep Formula and Pure Formulas…: allergen risk

February 25, 2026 · Pure Solutions Class II

Class IIFDA’s middle class: use of the product may cause temporary or medically reversible adverse health consequences, or the chance of serious harm is remote.
Reason for the recallLabel declares bovine colostrum but does not declare milk allergen.

Find the official FDA enforcement report

Recall at a glance

Recalling company
Pure Solutions
Location
Tampa, FL
Reported by FDA
February 25, 2026
Recall started
February 3, 2026
Risk class
Class II
Status (latest data we have)
Ongoing
Type
Voluntary: Firm initiated
Category
Supplements and infant formula
Reason type
Undeclared allergensLabeling and quality

Is my product affected?

Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.

  • 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)
    Quantity: 442 units (bottles)
    Codes: LOT: 0528D911 Expiration Date: May 2028

Where it was distributed

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

What to do

If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.

Frequently asked questions

What was recalled?

Pure Solutions recalled 1 product, including Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass….

Why was it recalled?

Label declares bovine colostrum but does not declare milk allergen.

What does Class II mean?

FDA’s middle class: use of the product may cause temporary or medically reversible adverse health consequences, or the chance of serious harm is remote.

Where was it sold or shipped?

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

What should I do if I have this product?

Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.

Similar recalls in supplements and infant formula

Sources

Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.