The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0631-2026·Announced 2026-06-24

Circle K triple antibiotic ointment recalled over manufacturing practice deviations

Circle K Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,420 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

Circle K Triple Antibiotic Ointment, containing bacitracin zinc 400 units, neomycin sulfate 3.5 mg and polymyxin-B sulfate 5,000 units, net weight 0.5 oz (14.2 g) tubes, manufactured for Lil' Drug Store Products, Inc., is being recalled. The action covers 2,420 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 0001 and 0005, 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
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, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC…
Manufacturer
Dabur India Limited
Category
Drug — Topical antibiotic ointment
Hazard
Affected units
2,420

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# 0001
  • and Lot# 0005
  • 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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