← FDA ENFORCEMENT
H-0537-2026Class II

Pure Solutions, Inc.

Recalling firm
Pure Solutions, Inc.
Product type
Food / supplement / cosmetic
Status
Ongoing
Report date
2026-02-25
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
Firm state
FL
Product quantity
442 units (bottles)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Label declares bovine colostrum but does not declare milk allergen.

Product description

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)

Code / lot info

LOT: 0528D911 Expiration Date: May 2028

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.