Liquid Dietary Supplements Recalled Due to Undeclared Milk Allergen
Pure Solutions, Inc. is recalling Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset because the labels do not declare milk as an allergen.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is due to allergen mislabeling (milk) on a dietary supplement, which is classified as High severity per the rubric.
Plain-English summary
Pure Solutions, Inc. is recalling Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, 1 fl oz (30 ml) liquid dietary supplements. The recall was initiated because the product labels declare bovine colostrum but fail to declare milk as an allergen.
This recall affects 442 individual 1 fl oz bottles with lot number 0528D911 and an expiration date of May 2028. The product was distributed to various states including 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.
Consumers should check their bottles for the affected lot number and expiration date. If you have the recalled product, do not consume it.
The recalled product
- Product
- 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)
- Manufacturer
- Pure Solutions, Inc.
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 442
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT: 0528D911 Expiration Date: May 2028
Distribution
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