Dietary Supplement Recall: Pure Solutions Nighttime Formula
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 |
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.
How to identify the recalled item
| Lot / date codes | LOT: 0528D911 Expiration Date: May 2028 |
|---|---|
| Lot / date codes | LOT: 0528D911 Expiration Date: May 2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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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.