HIGHFDA FOOD

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.

Official notice
Pure SolutionsFood & BeveragesLOT: 0528D911 Expiration Date: May 2028

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA FOOD
Recall date
February 3, 2026
Status
ACTIVE
Severity
7/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Food Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Pure Solutions
Product type
Liquid Dietary Supplement
Model numbers
LOT: 0528D911 Expiration Date: May 2028
Sold at
Multiple Retailers
Where affected
Nationwide

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 3, 2026

  2. Reported by FDA FOOD

    February 25, 2026

  3. RecallRadar source check

    March 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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

  1. Check the bottle for the lot number: 0528D911
  2. Verify the expiration date: May 2028
  3. 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.

Get instant alerts for Food & Beverages recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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
  • Stop using the product immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Food & Beverages Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLiquid Dietary Supplement
Sold At
Multiple Retailers

Product Details

Model Numbers
LOT: 0528D911 Expiration Date: May 2028
Affected States
Nationwide
Report Date
February 25, 2026
Source Agency
FDA - Food Safety
Recall Status
ACTIVE

Related Recalls