Lower risk Food recall · FDA · Published February 3, 2026

Pure Solutions Sleep Formula Recall: Label Missing Milk Allergen Warning

Pure Solutions recalls two sleep formulas for missing milk allergen warning on labels. Consumers should check product labels for bovine colostrum and milk allergen declaration.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #H-0537-2026Food Pure Solutions ›

Lower-risk recall

Label declares bovine colostrum but does not declare milk allergen.

Take action

Contact the company

Recalling firmPure Solutions, Inc.14100 Mccormick Dr · Tampa, FL 33626-3018

✎ GovInfoNow plain-language explainer

Pure Solutions is recalling two sleep formulas because they don: t label milk allergen even though they contain bovine colostrum. This could affect people with milk allergies who might not know the product contains milk. Read more at govinfonow.com/recall/6755-pure-solutions-sleep-formula-recall-label-missing-milk-allergen-warning.

Source Summary by GovInfoNow · govinfonow.com/recall/6755-pure-solutions-sleep-formula-recall-label-missing-milk-allergen-warning · Updated August 17, 2026 · Official notice: FDA #H-0537-2026

Cite this page

“Pure Solutions Sleep Formula Recall: Label Missing Milk Allergen Warning.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/6755-pure-solutions-sleep-formula-recall-label-missing-milk-allergen-warning. Based on FDA recall #H-0537-2026.

Pure Solutions, Inc. recalled Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset because the label fails to declare milk allergens despite listing bovine colostrum, according to the FDA. The Food and Drug Administration announced the Class II recall on Feb. 3, 2026.

How to tell if you have it

Brand: Pure Solutions
Products: Pure Factors Professional Nighttime Sleep Formula, Pure Formulas Sleep Reset
Size: 1 fl oz (30 ml) liquid in glass bottle with dropper cap
Lot code: 0528D911
Expiration date: May 2028
Units affected: 442 bottles

The hazard

The product label declares bovine colostrum but does not declare milk allergens, posing a risk to consumers with milk allergies. The FDA classified the recall as Class II.

Context

GovInfoNow's records show other recent recalls of similar products include Genepro Whey Protein Recall: Incorrect Allergen Labeling (2025-11-12) and Wawa Fruit Punch Pint Recall: Undeclared Milk Allergen Hazard (2026-04-02). Another Wawa Diet Iced Tea Lemon Pint Recall for undeclared milk allergen hazard was also reported on 2026-04-02.

How to tell if you have this one

Check for glass bottles with dropper caps labeled 'Pure Factors Professional Nighttime Sleep Formula' or 'Pure Formulas Sleep Reset', 1 fl oz (30 ml) size. Products were sold with lot number 0528D911 and expire May 2028.

Brand
Pure Solutions
Category
Food

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the label that states 'bovine colostrum' and whether milk allergen is declared.

Where it went and when

Where it was distributed

Distributed in 36 states.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 22 days after the firm started it.

Feb 3, 2026Firm started the recall
Feb 25, 2026Published in FDA’s Enforcement Report
Feb 27, 2026FDA classified it Class II

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/6755-pure-solutions-sleep-formula-recall-label-missing-milk-allergen-warning">Pure Solutions Sleep Formula Recall: Label Missing Milk Allergen Warning (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #H-0537-2026 (February 3, 2026)
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.