Glenmark Tacrolimus Ointment 0.1% Tubes May Split: Stop Using Now

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Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr, N/A · Mahwah, NJ 07430-2009

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Pharmaceuticals is recalling 0.1% Tacrolimus Ointment tubes that can split from the side seam. This defect could cause the ointment to leak or spill, potentially leading to skin irritation or infection if applied improperly.

Why it’s dangerous

The tube can split from the side seam, causing the ointment to leak or spill. This may lead to skin irritation, infection, or improper medication application if the ointment comes into contact with eyes or other areas.

Who’s affected

People with prescriptions for this ointment, especially those using it for skin conditions. Those with sensitive skin or who apply it frequently are at higher risk of irritation.

How to tell if you have this one

Check for 30g, 60g, or 100g tubes with NDC numbers 68462-534-35, 68462-534-65, or 68462-534-94. The product was manufactured in India and sold in the US with specific expiration dates listed in the recall.

Brand
Glenmark Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard any affected tubes to prevent leaks or spills that could cause skin irritation or infection.

✎ GovInfoNow

Questions people ask

Is this ointment safe to use?

No, the tubes may split, causing leaks that could lead to skin irritation or infection. Stop using immediately.

What is the NDC number for the recalled ointment?

The recalled ointment has NDC numbers 68462-534-35 (30g), 68462-534-65 (60g), and 68462-534-94 (100g).

How can I check if my tube is affected?

Check the tube's NDC number and expiration date against the list provided in the recall notice.

Take action

Contact Glenmark Pharmaceuticals

We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-1304-2022 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals

Hello,

I own a Glenmark Pharmaceuticals that is covered by recall D-1304-2022 from Glenmark Pharmaceuticals.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1304-2022 (July 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1304-2022 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Glenmark Pharmaceuticals Inc., USA recalls Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC

Use caution until it’s fixed