FDA-Food2026-02-25Class IIALLERGEN
Pure Solutions sleep formula recalled for undeclared milk allergen
What this means
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.
- Stop using this product immediately if you have a milk allergy or sensitivity.
- Check your bottles for lot number 0528D911 with expiration date May 2028.
- If you have a milk allergy and used this product, contact your doctor or poison control.
- Discard the product or return it where you bought it.
The agency's original wording
Hazard
Label declares bovine colostrum but does not declare milk allergen.
Intended for
Adults
Illnesses reported
None reported
Sold 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
Affected count
442 units (bottles)
Manufactured in
14100 Mccormick Dr, Tampa, FL, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0537-2026Want us to check the next one for you?
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