Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,
Akorn recalls 0.05% Azelastine HCl Ophthalmic Solution 6mL bottles due to impurities that could cause harm. This prescription eye drop is sold in HDPE bottles with specific lot numbers and expiration dates.
Recall notice
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling prescription eye drops containing Azelastine HCl 0.05% because impurities were found in the product. This could potentially cause harm to users, though the specific risk level isn't detailed in the recall notice. Read more at govinfonow.com/recall/39746-akorn-azelastine-ophthalmic-solution-0-0-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/39746-akorn-azelastine-ophthalmic-solution-0-0-impurities-may-cause-harm · Updated October 6, 2026 · FDA enforcement record: FDA #D-1168-2018
Cite this page
“Akorn Azelastine Ophthalmic Solution 0.0: Impurities May Cause Harm.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39746-akorn-azelastine-ophthalmic-solution-0-0-impurities-may-cause-harm. Based on FDA recall #D-1168-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1168-2018%22&limit=1).
Why it’s dangerous
The product failed impurities and degradation tests, showing results outside the acceptable range for Azelastine N-oxide. This could potentially lead to harmful effects in users, though the exact risk isn't specified in the recall.
Who’s affected
Prescription users of this eye drop, particularly those with specific lot numbers (6K89A, 6K90A, 6K92A) and expiration dates up to September 2018. People using the product without a prescription are not affected.
How to tell if you have this one
Check for the 6mL bottle with the lot numbers 6K89A, 6K90A, or 6K92A and expiration date of September 2018. The product is sold in HDPE bottles with a prescription requirement.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers 6K89A, 6K90A, or 6K92A and expiration date of September 2018 on the bottle.
Questions people ask
Is this product safe to use?
The recall states that impurities were found, but the specific risk level isn't detailed. The product may be unsafe, but the exact harm isn't specified in the notice.
What should I do if I have this product?
The recall does not provide a remedy, so no action is required beyond checking if your product matches the described lot numbers and expiration date.
How can I tell if I have the recalled product?
Check for the 6mL bottle with lot numbers 6K89A, 6K90A, or 6K92A and expiration date of September 2018.
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-1168-2018 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1168-2018 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-1168-2018 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1168-2018 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.