Akorn recalls all 0.5% moxifloxacin eye drops due to stability concerns after the manufacturer closed. No remedy provided; affected users should check NDCs and lots.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 0.5% moxif:loxacin eye drops because the company went out of business and can no longer ensure the product's stability. This means the medication may not be safe to use as intended.
The manufacturer closed and can no longer run stability tests, meaning the product's safety and effectiveness cannot be confirmed. This could lead to ineffective treatment or adverse reactions.
Prescription eye drop users who purchased the product from any source. Those with the product are most at risk due to potential stability issues.
Check for the product name 'Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles' on the label. All NDCs and lots are affected.
Identify the NDC and lot number on the bottle to confirm if it's affected.
The manufacturer closed and can no longer run stability tests, so the product's safety and effectiveness cannot be confirmed.
The recall record does not provide a remedy, so users should check product details and contact their healthcare provider for guidance.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0829-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0829-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
