FDA Drug Recalls

Recalls / Class II

Class IID-0173-2026

Product

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

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
381,619 units
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-0173-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls