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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Food
Food & Beverages/Dietary Supplements

Pure Solutions Dietary Supplements Recalled for Undeclared Milk Allergen

Agency Publication Date: February 13, 2026
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Summary

Pure Solutions, Inc. is recalling approximately 442 bottles of Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset liquid dietary supplements. The products contain bovine colostrum, which is a milk-derived ingredient, but the labels fail to declare that they contain milk. These 1 fl oz (30 ml) glass bottles were distributed across 35 U.S. states. Consumers with an allergy or severe sensitivity to milk should return the product to the place of purchase for a refund or throw it away.

Risk

People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. No illnesses or injuries have been reported to date.

What You Should Do

  1. Check your supplement bottles for 'Pure Factors Professional Nighttime Sleep Formula' or 'Pure Formulas Sleep Reset' in 1 fl oz (30 ml) glass bottles with dropper caps.
  2. Locate the lot number on your bottle. Affected products are marked with Lot 0528D911 and an expiration date of May 2028.
  3. Return the product to the place of purchase for a refund, throw it away, or contact Pure Solutions, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Pure Factors Professional Nighttime Sleep Formula (1 fl oz)by Pure Factors
Variants: Liquid dietary supplement
Item Code:
H-0537-2026
Lot Numbers:
0528D911 (Exp May 2028)

Glass bottle with dropper cap; individual bottles (not sold in case lots).

Product: Pure Formulas Sleep Reset (1 fl oz)by Pure Formulas
Variants: Liquid dietary supplement
Item Code:
H-0537-2026
Lot Numbers:
0528D911 (Exp May 2028)

Glass bottle with dropper cap; individual bottles (not sold in case lots).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98413
Status: Active
Manufacturer: Pure Solutions, Inc.
Manufactured In: United States
Units Affected: 442 units (bottles)
Distributed To: Arkansas, Florida, Colorado, California, Connecticut, Hawaii, Indiana, Illinois, Idaho, Iowa, Kansas, Kentucky, Louisiana, Ohio, Oklahoma, Oregon, Massachusetts, Michigan, Minnesota, Missouri, Georgia, North Carolina, Nebraska, North Dakota, New York, Pennsylvania, South Carolina, Tennessee, New Jersey, Utah, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming
Agency Last Updated: February 27, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.