Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake
Akorn recalls Gentamicin Sulfate Ophthalmic Solution 0.3% 5mL bottles due to crystalline particles found at 24-month testing. This may cause eye injury if used.
Lower-risk recall
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Gentamicin Sulfate Ophthalmic Solution 0.3% 5mL dropper bottles because crystalline particles were detected during 24-month testing. This could cause eye injury if the solution is used as intended. Read more at govinfonow.com/recall/39533-akorn-gentamicin-ophthalmic-solution-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/39533-akorn-gentamicin-ophthalmic-solution-recall-particulate-matter-hazard · Updated October 6, 2026 · FDA enforcement record: FDA #D-0414-2019
Cite this page
“Akorn Gentamicin Ophthalmic Solution Recall: Particulate Matter Hazard.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39533-akorn-gentamicin-ophthalmic-solution-recall-particulate-matter-hazard. Based on FDA recall #D-0414-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0414-2019%22&limit=1).
Why it’s dangerous
Crystalline particles were found in the solution during 24-month testing. These particles could potentially cause eye irritation or injury if the solution comes into contact with the eye during use.
Who’s affected
People with a prescription for this ophthalmic solution, especially those using it for eye infections. Those with sensitive eyes or using the solution for extended periods may be at slightly higher risk.
How to tell if you have this one
Check for the 5mL dropper bottle labeled 'Gentamicin Sulfate Ophthalmic Solution, USP 0.3%'. The product was manufactured by Akorn, Inc. in Lake Forest, IL with specific lot numbers: 6C02A (expires 02/19), 5K42A (expires 09/2018), or 7D47A (expires 03/2020).
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers 6C02A, 5K42A, or 7D47A on the bottle label.
Questions people ask
Is this product safe to use?
The recall is due to crystalline particles found during testing, which could cause eye injury. If you have the product, stop using it and contact your doctor.
What should I do if I have this product?
Check the lot number on the bottle. If it matches 6C02A, 5K42A, or 7D47A, stop using it and contact your doctor.
How can I confirm if my product is recalled?
Look for the lot numbers 6C02A (expires 02/19), 5K42A (expires 09/2018), or 7D47A (expires 03/2020) on the bottle label.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0414-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0414-2019 from Akorn. 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-0414-2019 (October 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0414-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.