FDA recall D-0638-2026

Dabur India Limited · Class II · drug

Product

Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.

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-0638-2026