Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL
Akorn recalls Gentamicin Sulfate Ophthalmic Solution (0.3%, 5mL) due to impurities detected at 18 months stability testing. This may cause eye injury if used improperly.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Gentamicin S: a prescription eye drop that may contain harmful impurities after 18 months of storage. Using this product could lead to eye injury if the impurities are present. Read more at govinfonow.com/recall/39156-akorn-gentamicin-ophthalmic-solution-recall-impurities-risk-eye-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/39156-akorn-gentamicin-ophthalmic-solution-recall-impurities-risk-eye-injury · Updated October 5, 2026 · FDA enforcement record: FDA #D-0993-2019
Cite this page
“Akorn Gentamicin Ophthalmic Solution Recall: Impurities Risk Eye Injury.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39156-akorn-gentamicin-ophthalmic-solution-recall-impurities-risk-eye-injury. Based on FDA recall #D-0993-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0993-2019%22&limit=1).
Why it’s dangerous
The eye drop may contain harmful impurities that were detected during stability testing at 18 months. These impurities could cause eye injury if the product is used without proper medical supervision.
Who’s affected
Prescription eye drop users who have the 5mL bottle labeled 'Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%'. Patients with eye infections requiring this medication are most at risk.
How to tell if you have this one
Check for the 5mL bottle labeled 'Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%' with NDC 17478-283-10. The product was manufactured for Akorn, Inc. in Lake Forest, IL, and expires January 2020.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Look for the 5mL bottle labeled 'Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%' with NDC 17478-283-10.
Questions people ask
Is this product safe to use?
The product may contain harmful impurities that could cause eye injury, so it should not be used without consulting a healthcare provider.
What should I do if I have this product?
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to use the product.
How can I tell if I have the recalled product?
Check for the 5mL bottle labeled 'Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%' with NDC 17478-283-10, manufactured in Lake Forest, IL, and expiring January 2020.
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-0993-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0993-2019 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-0993-2019 (February 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0993-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.