FDA recall D-0633-2026

Dabur India Limited · Class II · drug

Product

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.

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-0633-2026