FDA recall H-0537-2026 · Feb 25, 2026
Pure Solutions, Inc.: Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset recall
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 for recall
Label declares bovine colostrum but does not declare milk allergen.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your package, and look for the company's notice on FDA's recalls page. If you have the product and aren't sure, don't use it until you've checked.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- LOT: 0528D911 Expiration Date: May 2028
- 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
- Recalling firm
- Pure Solutions, Inc., Tampa, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-02-03
Source: openFDA enforcement record H-0537-2026 · search recall number H-0537-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 14, 2026, 1:15 AM EDT. The agency notice is the final word.
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