Pure Factors Professional Nighttime Sleep Formula and Pure Formulas…

Pure Solutions, Inc. has recalled Pure Factors Professional Nighttime Sleep Formula and Pure Formulas…, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on February 25, 2026 and was initiated on February 3, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Pure Factors Professional Nighttime Sleep Formula and Pure Formulas…, with approximately 442 units (bottles) affected. The company behind the recall is Pure Solutions, Inc., based in Tampa, FL. The FDA describes the product as: “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)”

Why was Pure Factors Professional Nighttime Sleep Formula and Pure Formulas… recalled?

According to the FDA, the stated reason for the recall is: “Label declares bovine colostrum but does not declare milk allergen.” In plain terms, this recall relates to an undeclared ingredient or allergen.

An undeclared ingredient means a food contains something — often a major allergen such as milk, eggs, soy, wheat, peanuts, or tree nuts — that is not listed on the label. For most people this is not dangerous, but for someone with a food allergy or sensitivity it can trigger a serious reaction. Accurate labeling is required so that people can avoid ingredients they need to stay away from.

What should you do?

If you think you may have bought Pure Factors Professional Nighttime Sleep Formula and Pure Formulas…, compare it against the product description and identifying codes (LOT: 0528D911 Expiration Date: May 2028) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Pure Solutions, Inc. or your local health authority.

About this recall

This recall was distributed in FL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.