Dietary Supplement Recall: Pure Solutions Nighttime Formula
Announced 2026-02-25 · FDA
FDA recalls 442 bottles of Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, a liquid dietary supplement in 1 fl oz glass bottles with a dropper cap. The recall is due to labeling that lists bovine colostrum but does not declare milk allergen. The affected product was distributed to multiple states; recall number LOT: 0528D911 with expiration May 2028; the recall is rated moderate by the FDA.
| Brand | Pure Solutions, Inc. |
|---|---|
| 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 | Label declares bovine colostrum but does not declare milk allergen. |
| Severity | moderate |
| Units affected | 442 |
| 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 |
| Agency | FDA |
| Recall / campaign no. | LOT: 0528D911 Expiration Date: May 2028 |
WHAT YOU SHOULD DO
- Discontinue use of any affected bottle and return it to the place of purchase or discard according to local regulations.
- Check your bottle for lot number 0528D911 and expiration date May 2028 to determine if it is part of the recall.
- If you have a milk allergy or exhibit symptoms after use, seek medical attention.
- Visit the FDA recall page or contact the manufacturer for guidance and to report any adverse effects.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.