Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B
Summary
The FDA issued a Class II for Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 unit by Dabur India Limited. Reason: CGMP Deviations; deficiencies observed during FDA inspection.
Details
Source
Drug Recall
External ID
D-0630-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
Product Description
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 (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.
Lot/Code Info: Lot# 0002, Lot# 0003, within expiry
Quantity Affected: 2503 tubes
Reason for Recall
CGMP Deviations; deficiencies observed during FDA inspection
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-02
Company
Dadra And Nagar Haveli
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Dabur India Limited has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dabur India Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dabur India Limited have FDA actions?
Dabur India Limited has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0630-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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