FDA recall D-0203-2026
Blossom Pharmaceuticals · Class II · drug
Product
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
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-0203-2026