Recall · openFDA Food Enforcement

Pure Factors Professional Nighttime Sleep Formula and Pure…: FDA Recall H-0537-2026

Agency action: Feb 3, 2026Record ID: H-0537-2026
View official source ↗

What happened

Original notice title

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…

From the archived source record

Label declares bovine colostrum but does not declare milk allergen.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Ongoing
FDA recall classification
Class II
Recall initiated by
Voluntary: Firm initiated
Report date
Feb 25, 2026
Source checked
Jul 16, 2026
Record revision
cd966dcaa309

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

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)
Company
Pure Solutions, Inc.
Lot / identifier
LOT: 0528D911 Expiration Date: May 2028
Market / 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