FDA-Drug2026-06-24Class IIPROCESSING DEFECT

Med Pride Bacitracin Zinc Ointment recalled for manufacturing quality deficiencies

OTHERNationwide distribution

Med Pride Bacitracin Zinc Ointment recalled for manufacturing deficiencies

The FDA identified manufacturing quality control problems during an inspection of the facility that produces Med Pride Bacitracin Zinc Ointment. Certain lot numbers do not meet federal manufacturing standards for sterile wound-care products.

  • Check your bacitracin ointment for lot numbers 007, 008, 009, 015, or 016.
  • Stop using the product if you have one of these lots.
  • Contact Shield Line LLC or your pharmacy for a refund or replacement.
  • Do not use the ointment on open wounds or broken skin.
Hazard

CGMP Deviations; deficiencies observed during FDA inspection

Sold states
US Nationwide.
Affected count
1087 tubes
Manufactured in
225 - 4 - 1 Saily Village, Survey No, Dadra And Nagar Haveli, India
Products
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.

Official notice

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

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