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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskFood

Pure Solutions, Inc. Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Recall 2026

Pure Solutions, Inc.Issued February 3, 2026

Pure Solutions, Inc. 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 sol — recalled per FDA on 2/3/2026. Reason: Label declares bovine colostrum but does not declare milk allergen..

Issuing agency
FDA
Issued
Feb 3, 2026
Brand
Pure Solutions, Inc.
Distribution
36 states

What to do right now

  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

  4. 4

    Clean prep surfaces

    Wash any utensils, cutting boards, or containers that touched the product with hot soapy water.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued February 3, 2026. Last synced Apr 16, 2026. View on fda.gov

What's recalled

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)

Undeclared allergen alert

This recall involves undeclared allergens not listed on the label:

milk

Why it was recalled

Label declares bovine colostrum but does not declare milk allergen.

Affected products & lot numbers
1 lot called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
LOT: 0528D911 Expiration Date: May 2028
Where was it sold
36 states

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

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View official FDA notice

View all questions for this recall →

More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the Pure Solutions, Inc. recall still active?

Yes, this recall is currently active as of February 3, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: LOT: 0528D911 Expiration Date: May 2028. Check the label on your product.

What should I do if I have the recalled Pure Solutions, Inc.?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.