The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0630-2026·Announced 2026-06-24

Lucky Super Soft triple antibiotic ointment recalled over manufacturing deviations

Lucky Super Soft First Aid Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,503 tubes are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall arising from inspection-observed manufacturing deviations with no product defect or consequence described, which fits the Moderate band.

Plain-English summary

Lucky Super Soft First Aid Triple Antibiotic Ointment, containing bacitracin zinc 400 units, neomycin sulphate 3.5 mg and polymyxin B sulphate 5,000 units, net weight 0.5 oz (14 g) tubes, manufactured for Delta Brands Inc. of Tarrytown, New York, is being recalled. The action covers 2,503 tubes.

The stated reason is CGMP deviations and deficiencies observed during an FDA inspection. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

Affected lots are 0002 and 0003, within expiry. Distribution was USA nationwide.

Consumers who have an affected lot should stop using it and follow the instructions issued by the firm.

The recalled product

Product
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…
Manufacturer
Dabur India Limited
Category
Drug — Topical antibiotic ointment
Hazard
Affected units
2,503

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot# 0002
  • Lot# 0003
  • within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Dabur India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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