Akorn recalls 2% piloc: 15mL eye drops (Rx only) because the manufacturer went out of business and can't do stability testing. No action needed as it's a prescription product.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 2% pilocarpine hydrochloride ophthalmic solution (15 mL bottles) because the company went out of business and can no longer perform stability tests. This is a prescription-only product with no immediate risk to users.
The manufacturer went out of business and can no longer conduct stability studies, which means the product's safety and effectiveness over time cannot be confirmed. This is a prescription-only medication, so it's not intended for general public use.
Prescription patients who have received this specific eye drop product. The risk is minimal as it's a controlled medication with no immediate safety concerns.
Check for 15 mL bottles labeled 'Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%'. This product is prescription-only and distributed by Akorn Operating Company LLC in Gurnee, Illinois.
Look for the product name and NDC numbers on the bottle label to confirm it's the recalled item.
The recall is due to the manufacturer going out of business and not being able to perform stability tests, but the product is prescription-only and has no immediate safety risks.
No action is needed as this is a prescription product with no immediate safety concerns. The recall is for the manufacturer's inability to verify stability, not an active hazard.
Check the product label for 'Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL' and the NDC numbers, which apply to all lots.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0861-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0861-2023 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.
