Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary
Summary
The FDA issued a Class II for Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, by Pure Solutions, Inc.. Reason: Label declares bovine colostrum but does not declare milk allergen..
Details
Source
Food Recall
External ID
H-0537-2026
Action Date
2026-02-25
Status
Ongoing
Category
food
Product 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)
Lot/Code Info: LOT: 0528D911 Expiration Date: May 2028
Quantity Affected: 442 units (bottles)
Reason for Recall
Label declares bovine colostrum but does not declare milk allergen.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-03
Company
Tampa, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 33 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pure Solutions, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pure Solutions, Inc. have FDA actions?
This is the only FDA action we have on record for Pure Solutions, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0537-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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