Pure Solutions, Inc. Recalls Sleep Supplements Due to Undeclared Milk Allergen

Source: FDA · United States

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Pure Solutions, Inc. is recalling 442 bottles of sleep supplements distributed across 36 states because the labels fail to declare a milk allergen.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 3, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Pure Solutions, Inc. of Tampa, Florida, has initiated a voluntary recall of two liquid dietary supplement products. The recall was triggered because the product labels declare bovine colostrum but fail to explicitly declare the presence of a milk allergen. This classification was designated as Class II by the FDA.

Which Products Are Affected

The recall involves 442 individual 1 fl oz (30 ml) bottles. The specific details are as follows:

  • Product Names: Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset
  • Packaging: Glass bottle with dropper cap
  • Lot Number: 0528D911
  • Expiration Date: May 2028
  • Recall Number: H-0537-2026

The affected units were distributed to the following states: 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, and WY.

What You Should Do

Consumers who have an allergy or severe sensitivity to milk should stop using these products immediately. Pure Solutions, Inc. has notified affected parties through various methods, including email, fax, letter, and telephone. Consumers with questions regarding returns or refunds should contact the firm directly at their Tampa, FL location.

Why This Matters

For individuals with a milk allergy, consuming these products poses a risk of serious or life-threatening allergic reactions. Accurate allergen labeling is essential for consumer safety and regulatory compliance.

Source

Information provided by the FDA regarding event ID 98413.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Pure Solutions, Inc. is recalling 442 bottles of sleep supplements distributed across 36 states because the labels fail to declare a milk allergen.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.