FDA Food recall ·
Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep… recall
- Recall number
- H-0537-2026
- Date
- (initiated February 3, 2026)
- Company / brand
- Pure Solutions, Inc.
14100 Mccormick Dr, Tampa, FL, United States - Category
- Food › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 442 units (bottles)
- Hazard tags
- Undeclared allergen
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Label declares bovine colostrum but does not declare milk allergen.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
LOT: 0528D911 Expiration Date: May 2028
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
States: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (food), recall H-0537-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.