Home/Recalls/FDA-D-0631-2026
FDA DrugsClass II

Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulf...

Published: June 24, 2026Recall ID: D-0631-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations; deficiencies observed during FDA inspection

Product Description & Identification

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 1 94283 65181 0.

Additional Source Details

FieldValue
CityDadra And Nagar Haveli
Event id99137
Address 1225 - 4 - 1 Saily Village
Address 2Survey No
Code infoLot# 0001, and Lot# 0005, within expiry
Postal codeN/A
Report date20260624
Product typeDrugs
Product quantity2420 tubes
Reason for recallCGMP Deviations; deficiencies observed during FDA inspection
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260602
Initial firm notificationE-Mail
Center classification date20260626

Overview

  • Recalling FirmDabur India Limited
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide.
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