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ACTIVE RECALL — CLASS IIActive recallH-0537-2026/FDA enforcement
Pure Solutions, INC.·Dietary Supplements·Feb 3, 2026

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, NET WT., 1 Fl…

What you need to know

Class II

  • What happened

    Label declares bovine colostrum but does not declare milk allergen.

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Active recall · classified by the FDAAR, FL, CO, CA +32 moreMore supplements

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Product identification

Source: FDA FOOD

Brand namePure Solutions, INC.
Recalling firmPure Solutions, INC.Tampa, FL, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • LOT: 0528D911 Expiration Date: May 2028
Distribution area
ARFLCOCACTHIINILIDIAKSKYLAOHOKORMAMIMNMOGANCNENDNYPASCTNNJUTTXVAWAWVWIWY

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

United States

Quantity affected442 units (bottles)
Recall initiationFDA report date: February 25, 2026
FDA recall numberH-0537-2026

Beyond the headline

The recall, in context

Pure Solutions, INC. initiated this supplements recall on February 3, 2026. The FDA enforcement report states: Label declares bovine colostrum but does not declare milk allergen. The FDA report lists distribution as: 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.

The FDA enforcement report describes the reason as: Label declares bovine colostrum but does not declare milk allergen.

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, NET WT., 1 Fl… was made or distributed by Pure Solutions, INC. in Tampa, FL, United States. This page reflects FDA report H-0537-2026, dated February 25, 2026.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared milk

Symptoms to watch for

Hives, swelling, wheezing, vomiting or anaphylaxis can occur in people with a milk allergy.

When symptoms may appear

Reactions can begin within minutes to a few hours after eating the product.

Higher-risk groups

People with a diagnosed cow's milk allergy, especially children and anyone with a history of anaphylaxis.

What to do now

  1. 1Do not eat the product if you have a milk allergy.
  2. 2Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis.
  3. 3Keep the packaging and contact the retailer or manufacturer about a refund.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, NET WT., 1 Fl… recall?

Pure Solutions, INC. recalled Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, NET WT., 1 Fl… in an FDA Class II enforcement action reported as H-0537-2026. Label declares bovine colostrum but does not declare milk allergen.

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Do not eat the product if you have a milk allergy. Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis. Keep the packaging and contact the retailer or manufacturer about a refund.

Is the Pure Solutions, INC. recall still active?

Yes. As of the latest FDA enforcement report, this recall is listed as ongoing. Check the official source record for the most current status before making a decision.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record H-0537-2026. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.