Recalls / Class II
Class IIH-0537-2026
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)
- Type
- Food
- Affected lot / code info
- LOT: 0528D911 Expiration Date: May 2028
- Quantity
- 442 units (bottles)
Why it was recalled
Label declares bovine colostrum but does not declare milk allergen.
Recalling firm
- Firm
- Pure Solutions, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 14100 Mccormick Dr, Tampa, Florida 33626-3018
Distribution
- Distribution pattern
- 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
Timeline
- Recall initiated
- 2026-02-03
- FDA classified
- 2026-02-27
- Posted by FDA
- 2026-02-25
- Status
- Ongoing
Source: openFDA Food Enforcement endpoint. Recall record H-0537-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings.