H-0537-2026
Pure Solutions, Inc.
Data retrieved 2026-10-27T22:06:49.008Z
Site-assigned category (for this product recall): Allergen & mislabeling
Independent website; not affiliated with or endorsed by FDA. Recall information is attributed to the linked FDA record. Categories are assigned by this website using keyword rules; they are not FDA classifications or independent legal findings and may be incomplete or incorrect. A category summarizes the stated reason for the identified product recall, not a finding about the firm generally or its other products. FDA’s original reason text appears below.
Official openFDA record · FDA recalls and safety alerts
Fields as reported by FDA
Dates are formatted YYYY-MM-DD. “Not reported” means the field was absent or empty.
- recall_number
- H-0537-2026
- event_id
- 98413
- recalling_firm
- Pure Solutions, Inc.
- city
- Tampa
- state
- FL
- country
- United States
- 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)
- reason_for_recall
- Label declares bovine colostrum but does not declare milk allergen.
- classification
- Class II
- FDA-reported status (not current status)
- Ongoing
FDA does not update this status after recall classification. It may not reflect whether the recall is currently ongoing, completed, or terminated. - voluntary_mandated
- Voluntary: Firm initiated
- 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
- product_quantity
- 442 units (bottles)
- code_info
- LOT: 0528D911 Expiration Date: May 2028
- recall_initiation_date
- 2026-02-03
- report_date
- 2026-02-25
- termination_date
- Not reported