FDA Drugs recall ·
Lantiseptic, Skin Protectant, Lanolin USP 30%… recall
- Recall number
- D-0170-2026
- Date
- (initiated August 27, 2025)
- Company / brand
- DermaRite Industries, LLC
7777 W Side Ave, North Bergen, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 57,837 units
- Hazard tags
- Microbial contamination Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Why was it recalled?
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots on or before expiry date 08/2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0170-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.