Glenmark Fluocinolone Ear Drops Recall: Failed Isopropyl Alcohol Test

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Pharmaceuticals is recalling fluocinolone acetonide ear drops due to a failed test for isopropyl alcohol. This could mean the product is unsafe for ear use, but the recall does not specify a remedy.

Why it’s dangerous

The ear drops failed a test for isopropyl alcohol content. This could mean the product is not safe for ear use, but the official notice does not explain how this affects safety.

Who’s affected

People who have the specific lot numbers of these ear drops (05220346, 05220369, 05220582, 05220861) are affected. Those using the product for ear drops are most at risk.

How to tell if you have this one

Check the lot number on the bottle label. The affected lots are 05220346 (exp 1/31/2024), 05220369 (exp 1/31/2024), 05220582 (exp 2/29/2024), and 05220861 (exp 3/31/2024).

Brand
Glenmark
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the bottle label to see if it matches the affected lots listed.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The product failed a test for isopropyl alcohol content, but the official notice does not specify how this affects safety.

What should I do if I have this product?

The official notice does not provide a remedy, so you should check the lot number and contact the manufacturer if you have the affected lots.

Is there a risk of serious injury from this product?

The official notice does not describe the hazard in enough detail to determine if there is a risk of serious injury.

Take action

Contact Glenmark

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

✉️ Open in email

Subject: Recall D-0259-2024 — Glenmark Glenmark

Hello,

I own a Glenmark that is covered by recall D-0259-2024 from Glenmark.

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-0259-2024 (January 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0259-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by:

Recall notice