What should I do if I have purchased the recalled sleep formula?

Stop using the product immediately and contact Pure Solutions, Inc. for refund or replacement information.

How can I identify if my product is affected by the recall?

Check the bottle for the lot number 0528D911 and expiration date of May 2028. If you have this lot, it is affected by the recall.

What are the risks of consuming this product?

The product contains bovine colostrum, which may cause allergic reactions in individuals sensitive to milk due to the undeclared milk allergen.

Where can I find more information about the recall?

Visit the FDA's website for detailed information about the recall and instructions for consumers.

Can I get a refund without a receipt?

Yes, consumers are entitled to a full refund regardless of receipt for the recalled product.

How long will it take to process my refund?

Typically, refunds are processed within 4-6 weeks after the request is submitted.

What happens if I experience an allergic reaction after consuming the product?

Seek medical attention immediately and report the incident to Pure Solutions and the FDA.

Is this recall part of a larger trend in dietary supplements?

This recall highlights the importance of accurate labeling in dietary supplements, particularly regarding allergens.

Will I receive a notification about the recall?

Yes, Pure Solutions will notify consumers through email, fax, letter, or press release.

What alternative products can I use instead of the recalled sleep formula?

You might consider trying melatonin supplements, valerian root supplements, or chamomile tea as safer alternatives.

HIGHFebruary 3, 2026

Pure Solutions Recalls Sleep Formula Over Milk Allergen Risk

Pure Solutions recalled 442 bottles of its sleep supplements on February 3, 2026. The labels did not declare a milk allergen despite containing bovine colostrum. Consumers should stop using the product immediately and seek refunds.

Quick Facts at a Glance

Recall Date: February 3, 2026
Hazard Level: HIGH
Brand: Pure Solutions
Category: Food & Beverages
Sold At: Multiple Retailers
Geographic Scope: Nationwide (50 states)
At-Risk Groups: GENERAL

Hazard Information

Label declares bovine colostrum but does not declare milk allergen.

What You Should Do

Consumers who have purchased this product should not consume it. Contact Pure Solutions, Inc. for refund or replacement information. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

The Pure Factors Professional Nighttime Sleep Formula is a liquid dietary supplement designed to support sleep. Consumers typically purchase this product for its natural sleep-enhancing properties.

Why This Is Dangerous

The product's labeling fails to disclose the presence of milk allergens, which can pose health risks to individuals with milk allergies.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may lead to inconvenience for consumers who relied on the product for sleep support and raises concerns about labeling practices in dietary supplements.

Practical Guidance

How to identify if yours is affected

Check the bottle for the lot number: 0528D911
Verify the expiration date: May 2028
If both match, your product is affected by the recall.

Where to find product info

Look for the lot number and expiration date printed on the label of the bottle.

What timeline to expect

Expect a refund or replacement processing timeline of 4-6 weeks.

If the manufacturer is unresponsive

Contact Pure Solutions via email or phone for updates.
Keep records of your communication attempts.

How to prevent similar issues

Always check labels for allergen declarations before purchasing supplements.
Look for certifications indicating compliance with labeling standards.

Documentation advice

Document your purchase with photos of the product, receipts, and any correspondence with the company.

Product Details

The recalled products are Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset. Each bottle contains 1 fl oz (30 ml) of liquid dietary supplement. The affected lot number is 0528D911 with an expiration date of May 2028.

Key Facts

Recalled product: Pure Factors Professional Nighttime Sleep Formula
Label lacks milk allergen declaration
442 units affected
Stop using the product immediately

View Original Recall on FDA - Food Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryFood & Beverages › Dietary Supplements

Product TypeLiquid Dietary Supplement

Product Details

Brand

Pure Solutions

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