Why it was recalled
CGMP Deviations; deficiencies observed during FDA inspection
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.
Lot numbers, UPCs & expiration codes
Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 023, 024, 025, 027, 028, 029, 031, 032, 033, 034, 035, Within Expiry.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0642-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 2, 2026
- FDA report date
- Jun 24, 2026
- Quantity
- 8996 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dabur India Limited
Original FDA data
Every field from FDA enforcement report D-0642-2026, exactly as published.
Show all FDA fields
- City
- Dadra And Nagar Haveli
- Status
- Ongoing
- Country
- India
- Event ID
- 99137
- Address
- 225 - 4 - 1 Saily Village
- Address (line 2)
- Survey No
- Code information
- Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 023, 024, 025, 027, 028, 029, 031, 032, 033, 034, 035, Within Expiry.
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0642-2026
- Classification
- Class II
- Recalling firm
- Dabur India Limited
- Product quantity
- 8996 tubes
- Reason for recall
- CGMP Deviations; deficiencies observed during FDA inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jun 2, 2026
- Initial firm notification
- Center classification date
- Jun 26, 2026