Class IIOngoingVoluntary: Firm initiated
Pure Solutions, Inc.: food recall H-0537-2026
Pure Solutions, Inc. of Tampa, FL recalled Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid… Reason: Label declares bovine colostrum but does not declare milk allergen. The FDA listed it as Class II in its Enforcement Report dated Feb 25, 2026; distribution: Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming.
Record status as published: Ongoing. openFDA data last updated Oct 21, 2026.
Have this product? Check FDA.gov and your retailer. This page reproduces an FDA Enforcement Report record and is not a public alert. Look for the firm's recall notice on the FDA's recalls page, or ask the store where you bought it what to do. If you think you got sick from a food, contact a health care provider.
Recall details
- 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)
- Product quantity
- 442 units (bottles)
- Reason for recall
- Label declares bovine colostrum but does not declare milk allergen.
- Codes, lots and dates on the package
- LOT: 0528D911 Expiration Date: May 2028
- 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
- Recalling firm
- Pure Solutions, Inc., Tampa, FL
- Classification
- Class II — the FDA uses this class for a situation in which using or being exposed to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
- Voluntary or mandated
- Voluntary: Firm initiated
- How the firm first notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Dates
| Event | Date |
|---|---|
| Recall initiated by the firm | Feb 3, 2026 |
| Classified by the FDA | Feb 27, 2026 |
| Published in the Enforcement Report | Feb 25, 2026 |
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Sources
- U.S. Food and Drug Administration, openFDA food enforcement reports, recall number H-0537-2026 (openFDA record). Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
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