CLASS II ONGOING Food recall · Reported 25 Feb 2026 · FDA Enforcement Report

Pure Factors Professional Nighttime Sleep Formula recalled

Pure Solutions is recalling Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, distributed in 36 states. The recall was initiated on 3 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT: 0528D911 Expiration Date: May 2028

Quantity recalled442 units (bottles)

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: H-0537-2026
FDA event ID: 98413
Recalling firm: Pure Solutions, Tampa, FL
Classification: Class II
Status: Ongoing
Recall initiated: 3 Feb 2026
FDA classified: 27 Feb 2026
Reported: 25 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Undeclared Milk
Product category: Dietary Supplements

Timeline

3 Feb 2026	Recall initiated by company
25 Feb 2026	Published in enforcement report	+22 days
27 Feb 2026	Classified by FDA	+2 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Label declares bovine colostrum but does not declare milk allergen.

Product as listed by the FDA

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)

Where it was distributed

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

Arkansas California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri North Carolina North Dakota

Questions about this recall

Why was it recalled?

Label declares bovine colostrum but does not declare milk allergen.

Which lots are affected?

LOT: 0528D911 Expiration Date: May 2028

Where was it sold?

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

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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