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FDA recall, , Moderate risk

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset

The liquid dietary supplement labels declare bovine colostrum but do not declare milk allergen.

Recall ended Oct 23, 2026. Still check yours.

Summary by Recall Canary from the FDA notice

What happened

Pure Solutions, Inc., of Tampa, Florida, recalled Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplements in glass bottles with dropper caps because the label declares bovine colostrum but does not declare milk allergen. The recall began February 3, 2026, and was added to the FDA's Enforcement Report on February 13, 2026.

More undeclared milk recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for food recalls:

  1. Return it to the store where you bought it, or throw it away.
  2. Don't give it to anyone else, such as a food bank, or to a pet.

Is your bottle affected?

Affected if its lot code matches.

  1. 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)

    Lot code
    • 0528D911

Recall details

Company began the recall
Sold in
36 states
Company
Pure Solutions, Inc.Tampa, Florida
Hazard
Undeclared milk
Risk

Moderate risk

Eating it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98413
Recall number
H-0537-2026
Quantity recalled
442 units (bottles)

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report

  3. In FDA's weekly enforcement report

  4. Classified by FDA

  5. Listed on Recall Canary

  6. Recall ended

  7. Summary updated

Other undeclared milk recalls

See all: Other undeclared milk recalls

Summary by Recall Canary, written with AI · summary updated Oct 24, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)