Akorn recalls all Olopat: 665 mcg nasal spray bottles due to company closure halting stability testing. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Olopatadine HCl Nasal Spray bottles (665 mcg, 30.5g) because the company went out of business and can no longer perform stability tests. This means the product's safety and effectiveness cannot be guaranteed.
The company went out of business and stopped stability testing, which means the product's safety and effectiveness over time cannot be confirmed. This could lead to unpredictable reactions or reduced effectiveness.
People who have prescription Olopatadine HCl Nasal Spray bottles from Akorn. Those with the product are most at risk due to potential instability.
Check for Akorn Olopatadine HCl Nasal Spray bottles labeled 665 mcg, 30.5g, and prescription-only. All products from the manufacturer are affected.
Identify if your bottle has the label 'Olopatadine HCl Nasal Spray, 665 mcg, 30.5g' and is prescription-only.
The company went out of business and could no longer continue stability studies, so the product's safety and effectiveness cannot be guaranteed.
The recall does not specify a stop-use instruction, but the product's stability is unconfirmed due to the company's closure.
The official notice states no remedy is provided.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0832-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0832-2023 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.