Akorn recalls 5% Sodium Chloride Ophthalmic Solution due to subpotent drug concentration
Akorn recalls 5% Sodium Chloride Ophthalmic Solution bottles with subpotent drug concentration. This means the solution contains less active ingredient than labeled, potentially reducing effectiveness for eye irrigation.
Lower-risk recall
Subpotent Drug: concentration of product is less than labeled amount.
Contact the company
What happened, in plain English
Akorn is recalling 5% Sodium Chloride Ophthalmic Solution bottles because the concentration of the solution is less than labeled. This could mean the solution is less effective for eye irrigation than intended. Read more at govinfonow.com/recall/42284-akorn-recalls-5-sodium-chloride-ophthalmic-solution-due-to-subpotent.
Source Summary by GovInfoNow · govinfonow.com/recall/42284-akorn-recalls-5-sodium-chloride-ophthalmic-solution-due-to-subpotent · Updated October 9, 2026 · FDA enforcement record: FDA #D-0124-2017
Cite this page
“Akorn recalls 5% Sodium Chloride Ophthalmic Solution due to subpotent drug concentration.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42284-akorn-recalls-5-sodium-chloride-ophthalmic-solution-due-to-subpotent. Based on FDA recall #D-0124-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0124-2017%22&limit=1).
Why it’s dangerous
The solution has a lower concentration of active ingredient than labeled, which could reduce its effectiveness for eye irrigation. This may not cause serious harm but could lead to inadequate treatment in medical situations.
Who’s affected
People who use this eye irrigation solution for medical purposes may be affected. Those with specific medical conditions requiring precise saline concentrations are at higher risk.
How to tell if you have this one
Look for bottles labeled 'Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL' from Akorn, Inc. in Lake Forest, IL. The product has NDC 17478-623-12 and lot number 041306A.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Verify the product label for the NDC number 17478-623-12 and lot number 041306A.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0124-2017 (October 21, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0124-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.