Moderate riskFDA FoodClass II

Pure Factors sleep supplement recalled for undeclared milk allergen

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset contain bovine colostrum, which is a milk product, but the label does not warn about the milk allergen. People with milk allergies could have a serious reaction if they use this product.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using this product immediately if you have a milk allergy or sensitivity.
  2. Check your bottles for lot number 0528D911 with expiration date May 2028.
  3. If you have a milk allergy and used this product, contact your doctor or poison control.
  4. Discard the product or return it where you bought it.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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)
Sold in
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
Made for
Adults

Details

Units affected
442 units (bottles)
Illnesses reported
None reported
Manufactured in
14100 Mccormick Dr, Tampa, FL, United States
Classification
Class II
Recall number
H-0537-2026

In the FDA's words

Description
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) Label declares bovine colostrum but does not declare milk allergen. LOT: 0528D911 Expiration Date: May 2028 Distribution: 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 Affected quantity: 442 units (bottles)
Hazard
Label declares bovine colostrum but does not declare milk allergen.

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