FDA-Drug2026-06-24Class IIPROCESSING DEFECT
Med Pride Bacitracin Zinc Ointment recalled for manufacturing quality deficiencies
What this means
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.
The agency's original wording
Hazard
CGMP Deviations; deficiencies observed during FDA inspection
Intended for
All ages
Illnesses reported
None reported
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-0635-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.