# FDA recall H-0537-2026

> **Pure Solutions, Inc.** · Class II · food recall initiated 2026-02-03.

## 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)

## Reason for recall

Label declares bovine colostrum but does not declare milk allergen.

## Distribution

Product was distributed to: 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, WY

## Key facts

- **Recall number:** H-0537-2026
- **Recalling firm:** Pure Solutions, Inc.
- **Classification:** Class II
- **Product type:** food
- **Status:** Ongoing
- **Initiation date:** 2026-02-03
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0537-2026

## Citation

> AI Analytics. FDA recall H-0537-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/H-0537-2026. Source: US FDA. Licensed CC0.

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