Class II U.S. Food and Drug Administration

Glenmark Pharmaceuticals Inc., USA Azelaic Acid Gel, 15%, 50 gram tubes recall: CGMP Deviations: Product quality complaints concerning abnormal texture

Recall published 3 months ago

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

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: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

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-0731-2026
Published
August 5, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Glenmark Pharmaceuticals Inc., USA
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.

Products covered by this recall

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • 19260937A

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • February 2028
  • March 2028
  • April 2028. — N

NDC number

On the carton and again on the bottle or blister label.

  • 68462-626-52

Package size

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

  • 50 gram

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

Glenmark Pharmaceuticals Inc., USA — 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. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
  3. Return the affected pack to the pharmacy for a replacement from a good lot.
  4. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.

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: Glenmark Pharmaceuticals Inc., USA — 619 River Dr, Elmwood Park, NJ, 07407-1317

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 Glenmark Pharmaceuticals Inc., USA prescription & otc drugs recalled?

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 19260937A; best-by date February 2028 or March 2028. 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.

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