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

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.