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Food FDA Class II Ongoing Undeclared allergen

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)

Pure Solutions, Inc. Published Feb 25, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 67/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • If you are allergic or sensitive to the ingredient noted, do not eat it — it could cause a serious reaction.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Pure Solutions, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Label declares bovine colostrum but does not declare milk allergen.

Hazards

Milk · primary

Affected products (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)

442 units (bottles)

Lot codes: 0528D911
Code info: LOT: 0528D911 Expiration Date: May 2028

Affected areas

ArkansasCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriNebraskaNew JerseyNew YorkNorth CarolinaNorth DakotaOhioOklahomaOregonPennsylvaniaSouth CarolinaTennesseeTexasUtahVirginiaWashingtonWest VirginiaWisconsinWyoming

Timeline

  1. Initiated
    Feb 3, 2026
  2. Published
    Feb 25, 2026
Recall number
H-0537-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA food enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.