FDA recall D-0635-2026

Dabur India Limited · Class II · drug

Product

Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.

Reason for recall

CGMP Deviations; deficiencies observed during FDA inspection

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-06-02
Report date
2026-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dadra And Nagar Haveli, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0635-2026