FDA Drug Recalls

Recalls / Class II

Class IID-0201-2026

Product

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

Affected lot / code info
Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.

Why it was recalled

cGMP deviations

Recalling firm

Firm
Blossom Pharmaceuticals
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, N/A, India

Distribution

Quantity
9600 containers
Distribution pattern
USA Nationwide

Timeline

Recall initiated
2025-10-31
FDA classified
2025-12-02
Posted by FDA
2025-12-10
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0201-2026. 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