← FDA ENFORCEMENT
D-0635-2026Class II

Dabur India Limited

Recalling firm
Dabur India Limited
Product type
Drug
Status
Ongoing
Report date
2026-06-24
Distribution
US Nationwide.
Product quantity
1087 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations; deficiencies observed during FDA inspection

Product description

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.

Code / lot info

Lot# 007, 008, 009, 015, 016, Within Expiry.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.