Pure Solutions, Inc. Recalls Sleep Supplements Due to Undeclared Milk Allergen
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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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