Akorn Recalls Sulfacetamide Sodium Eye Drops Due to Sterility Risk
Akorn recalls specific lots of Sulfacetamide Sodium Ophthalmic Solution due to lack of sterility assurance. Check lot numbers and expiry dates immediately.
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Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
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What happened, in plain English
Akorn, Inc. is recalling Sulfacetamide Sodium Ophthalmic Solution, USP, 10% because some lots failed antimicrobial effectiveness testing on stability. This means the product may not remain sterile as intended during its shelf life. The recall affects 57,920 bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42660-akorn-recalls-sulfacetamide-sodium-eye-drops-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42660-akorn-recalls-sulfacetamide-sodium-eye-drops-due-to-sterility-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0949-2016
Cite this page
“Akorn Recalls Sulfacetamide Sodium Eye Drops Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42660-akorn-recalls-sulfacetamide-sodium-eye-drops-due-to-sterility-risk. Based on FDA recall #D-0949-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0949-2016%22&limit=1).
Why it’s dangerous
The solution failed antimicrobial effectiveness testing on stability, meaning it lacks assurance of sterility. Using eye drops that are not sterile can introduce bacteria or other pathogens into the eye, potentially causing severe infection or injury.
Who’s affected
Patients who have been prescribed or purchased Sulfacetamide Sodium Ophthalmic Solution from Akorn between the manufacturing dates of the affected lots. Users are at risk if they use non-sterile eye drops, which can lead to serious eye infections.
How to tell if you have this one
Look for 15 mL bottles labeled 'Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only' manufactured by Akorn, Inc. Check the NDC 17478-221-12 and specific lot numbers: 5A17A (Expiry 06/16), 5K21A (Expiry 03/17), or 6A08A (Expiry 06/17).
- Brand
Akorn- Category
Drug
What to do — step by step
Stop using the product
Do not use any eye drops matching the recalled lot numbers and expiry dates listed above.
Check your bottle details
Verify if your bottle has NDC 17478-221-12 and one of the specific lot numbers (5A17A, 5K21A, or 6A08A) with the corresponding expiry dates.
Contact your pharmacist
Speak with your pharmacy or healthcare provider to determine if you have a recalled bottle and how to replace it.
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 14 months 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.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the recalled product is 17478-221-12.
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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-0949-2016 (May 17, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0949-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b 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.