FDA recall D-0204-2026

Blossom Pharmaceuticals · Class II · drug

Product

Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.

Reason for recall

cGMP deviations

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-10-31
Report date: 2025-12-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bardej, Goa, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0204-2026