Akorn recalls 1%, 2mL, 5mL, and 15mL ophthalmic atropine solutions due to stability testing halted after company went out of business. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 1% atropine eye drops (2mL, 5mL, and 15mL bottles) because the company went out of business and can no longer test product stability. This means the medication may not be safe for use as the company can't confirm it remains stable.
The recall happens because Akorn went out of business and stopped doing stability tests. Without these tests, the medication's safety and effectiveness over time can't be confirmed. This could mean the drops might not work properly or could cause eye issues.
People who have prescription atropine eye drops from Akorn, Inc. are affected. Those with the medication for eye conditions like glaucoma or post-surgery are most at risk.
Check for Akorn brand eye drops labeled 1% concentration in 2mL, 5mL, or 15mL bottles. All products were distributed by Akorn Operating Company LLC in Gurnee, Illinois.
Look for the product name and packaging details on the label to confirm it matches the recalled items.
The official recall notice does not provide any remedy or fix for this issue.
Check for Akorn brand eye drops labeled 1% concentration in 2mL, 5mL, or 15mL bottles. All products were distributed by Akorn Operating Company LLC in Gurnee, Illinois.
The recall notice does not specify a stop-use instruction, so you can continue using it if you have it, but the company no longer tests the product's stability.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0779-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0779-2023 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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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.
