DermaRite Industries, LLC: Drug Recall
Recall #D-0166-2026 · 08/27/2025
Class II: Risk
Recall Details
- Recall Number
- D-0166-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- DermaRite Industries, LLC
- Status
- Ongoing
- Date Initiated
- 08/27/2025
- Location
- North Bergen, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115,994 containers
Reason for Recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Product Description
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Distribution Pattern
Nationwide in the USA
Other Recalls by DermaRite Industries, LLC
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.