Recalls / Class II
Class IID-0164-2026
Product
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
- Affected lot / code info
- All lots on or before expiry date 08/2027
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recalling firm
- Firm
- DermaRite Industries, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7777 W Side Ave, North Bergen, New Jersey 07047-6436
Distribution
- Quantity
- 2,673 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-27
- FDA classified
- 2025-11-20
- Posted by FDA
- 2025-11-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0164-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.