Pure Solutions, Inc. Recall: Label declares bovine colostrum but does not declare milk allergen.
United States
OngoingClass II
- Company
- Pure Solutions, Inc.
- Product
- Pure Factors Professional Nighttime Sleep Formula and Pure F…
- Recall date
- February 3, 2026
- Source
- FDA
Reason for recall
Label declares bovine colostrum but does not declare milk allergen.
- - Recall initiated
- - Reported by source
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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) | Not published in this source record | 442 units (bottles) | 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
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- H-0537-2026
- Event ID
- 98413
- Status
- Ongoing
- Classification
- Class II
- Company
- Pure Solutions, Inc.
- 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)
- Quantity
- 442 units (bottles)
- Reason
- Label declares bovine colostrum but does not declare milk allergen.
- Recall initiation date
- February 3, 2026
- Report date
- February 25, 2026
- Classification date
- Not published in this source record
- Termination date
- Not terminated as of this source record
- 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
- UPC, lot, and code information
- LOT: 0528D911 Expiration Date: May 2028
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Pure Solutions, Inc.
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Arkansas | 1 |
| Florida | 1 |
| Colorado | 1 |
| California | 1 |
| Connecticut | 1 |
| Hawaii | 1 |
| Indiana | 1 |
| Illinois | 1 |
| Idaho | 1 |
| Iowa | 1 |
| Kansas | 1 |
| Kentucky | 1 |
| Louisiana | 1 |
| Ohio | 1 |
| Oklahoma | 1 |
| Oregon | 1 |
| Massachusetts | 1 |
| Michigan | 1 |
| Minnesota | 1 |
| Missouri | 1 |
| Georgia | 1 |
| North Carolina | 1 |
| Nebraska | 1 |
| North Dakota | 1 |
| New York | 1 |
| Pennsylvania | 1 |
| South Carolina | 1 |
| Tennessee | 1 |
| New Jersey | 1 |
| Utah | 1 |
| Texas | 1 |
| Virginia | 1 |
| Washington | 1 |
| West Virginia | 1 |
| Wisconsin | 1 |
| Wyoming | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
