Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl…
Recalling firm: Pure Solutions, Inc.
Label declares bovine colostrum but does not declare milk allergen.
Check your package
Compare the exact product and package details with the label you have.
FDA code information
LOT: 0528D911 Expiration Date: May 2028
Match the product, package size, and code together. A missing match does not guarantee safety.
Full FDA record and distribution details
Original 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)
Extracted codes and context
| Type | Code / value | Context |
|---|---|---|
| lot | 0528D911 | LOT: 0528D911 Expiration Date: May 2028 |
Original FDA recall reason
Label declares bovine colostrum but does not declare milk allergen.
Recall details
- Recall number
- H-0537-2026
- Event ID
- 98413
- FDA status
- Ongoing
- Initiated
- Feb 3, 2026
- Reported
- Feb 25, 2026
- Classified
- Feb 27, 2026
- Quantity
- 442 units (bottles)
- Location
- Tampa, FL, United States
- Initiation type
- Voluntary: Firm initiated
- Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Where it was distributed
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
Data updated September 16, 2026. View official FDA data ↗
Follow official FDA and manufacturer guidance.