Class II U.S. Food and Drug Administration

Dabur India Limited Circle K, triple antibiotic ointment, Bacitracin Zinc recall: CGMP Deviations; deficiencies observed during FDA inspection

Recall published 4 months ago

CGMP Deviations; deficiencies observed during FDA inspection

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: CGMP Deviations; deficiencies observed during FDA inspection

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0631-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Dabur India Limited
Product type
Prescription & OTC drugs
Units affected
2420 tubes
Distribution
Nationwide
Sold at
Circle K
Made in
India
Lot / code info
Lot# 0001, and Lot# 0005, within expiry
UPC codes
194283651810

Products covered by this recall

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.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 194283651810

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0001
  • Lot# 0005

Model or item number

On the rating label, the box or the instruction sheet.

  • 9300 Earhart Lane SW
  • IA 524

Package size

Match the net weight or the piece count on the front of the pack.

  • 3.5 mg
  • 0.5 oz

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Dabur India Limited — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Return the affected pack to the pharmacy for a replacement from a good lot.
  3. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  4. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Dabur India Limited — 225 - 4 - 1 Saily Village, Dadra And Nagar Haveli

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Dabur India Limited prescription & otc drugs recalled?

CGMP Deviations; deficiencies observed during FDA inspection CGMP Deviations; deficiencies observed during FDA inspection

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 194283651810; lot code 0001, Lot# 0005; model number 9300 Earhart Lane SW, IA 524. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide, including at Circle K.

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