Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset recall
Recalled by Pure Solutions, Inc. · Tampa, FL, United States
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Label declares bovine colostrum but does not declare milk allergen.
Undeclared allergen: Milk
For someone with a food allergy the label is the only protection. An undeclared allergen can trigger a severe reaction even in a trace amount, which is why most of these recalls are Class I. All undeclared allergens recalls.
What was 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)
Quantity: 442 units (bottles)
Lot codes, dates and UPCs
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
LOT: 0528D911 Expiration Date: May 2028
Where it was sold
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
FDA's distribution note: 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
Check the codes, then return or discard. Class II means eating it may cause temporary or reversible health problems. If your package matches the recalled codes, do not eat it - return it to the store or throw it away. The risk from an undeclared allergen is to people allergic to milk; for anyone else the product is generally not a safety concern.
- Recalling firm
- Pure Solutions, Inc.
- Initiated by
- Voluntary: Firm initiated
- Recall initiated
- Feb 3, 2026
- In FDA report of
- Feb 25, 2026
- FDA recall number
- H-0537-2026 · event 98413
- Official record
- FDA enforcement report search