FDA recall record

Dabur India Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin recall — FDA D-0642-2026

CGMP Deviations; deficiencies observed during FDA inspection

Class IIclassification
D-0642-2026official record ID
Jun 24, 2026report date

Recall record at a glance

Official recordD-0642-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmDabur India Limited
Report dateJun 24, 2026
Recall initiation dateJun 2, 2026
Quantity8996 tubes
LocationDadra And Nagar Haveli, India

Official product description

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.

Why the product was recalled

CGMP Deviations; deficiencies observed during FDA inspection

Distribution information

US Nationwide.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.

Related recall records

Other records from the same recalling company are shown first when available.