FDA recall D-0637-2026

Product

Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.

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-0637-2026