Med Pride bacitracin zinc ointment recalled for CGMP deviations
The FDA identified manufacturing quality control problems during an inspection of the facility that produces Med Pride Bacitracin Zinc Ointment. Certain lot numbers do not meet federal manufacturing standards for sterile wound-care products.
From the FDA notice · Read the official notice ↗
What to do
- Check your bacitracin ointment for lot numbers 007, 008, 009, 015, or 016.
- Stop using the product if you have one of these lots.
- Contact Shield Line LLC or your pharmacy for a refund or replacement.
- Do not use the ointment on open wounds or broken skin.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- UPC code
- 352410303524
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 14 products — see all of them.
Details
- Units affected
- 1087 tubes
- Illnesses reported
- None reported
- Manufactured in
- 225 - 4 - 1 Saily Village, Survey No, Dadra And Nagar Haveli, India
- Classification
- Class II
- Recall number
- D-0635-2026
In the FDA's words
- 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. CGMP Deviations; deficiencies observed during FDA inspection Lot# 007, 008, 009, 015, 016, Within Expiry. Distribution: US Nationwide. Affected quantity: 1087 tubes
- Hazard
- CGMP Deviations; deficiencies observed during FDA inspection
14 products in this recall
Med Pride, Lucky and more creams recalled for quality issues
Dabur is recalling 14 antibiotic and antifungal creams, ointments and first aid products, including Lucky Super Soft, Circle K, Lil Drug Store, Rapidol, Cura Hongos and Med Pride. The FDA found manufacturing quality problems (CGMP deviations) during an inspection. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains…D-0629-2026 · 1102 tubes
- Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz…D-0630-2026 · 2503 tubes
- Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes,…D-0631-2026 · 2420 tubes
- Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g),…D-0632-2026 · 1225 tubes
- 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,…D-0633-2026 · 84 tubes
- Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.D-0634-2026 · 84 tubes
- 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 U… (this page)D-0635-2026 · 1087 tubes
- Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC…D-0636-2026 · 4374 tubes
- Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in…D-0637-2026 · 1185 tubes
- 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…D-0638-2026 · 5755 tubes
- Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 5…D-0639-2026 · 4,738 tubes
- Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3…D-0640-2026 · 4,944 tubes
- Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets pe…D-0641-2026 · 3006 tubes
- Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield…D-0642-2026 · 8996 tubes