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Drug FDA Class II Ongoing Contamination / non-sterility

Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.

Brands International Corporation Published Jul 24, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Brands International Corporation or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination

Hazards

Mold · primary

Affected products (1)

Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.

120,319 bottles

Lot codes: 24092009
Code info: Lot# 24092009, Exp 03/27; 24094010, Exp 04/27

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 10, 2024
  2. Published
    Jul 24, 2024
Recall number
D-0598-2024
Agency
U.S. Food and Drug Administration
Country
US

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.