San-E-Foam recalled over manufacturing violations
- Recall date
- August 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- DermaRite Industries, LLC recalls San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Ber…
- Recall number
- D-0176-2026
- FDA classification
- Class II
- Brand / firm
- DermaRite Industries, LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
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