Akorn recalls 4% pilocarpine eye drops (15mL) because the manufacturer went out of business and can't continue stability testing. All products are affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 4% piloc:hydrochloride eye drops (15mL) because the company went out of business and can no longer test product stability. This means the medication may not be safe for use.
The manufacturer went out of business and can no longer perform stability studies. This means the product's safety and effectiveness could be compromised over time.
Prescription eye drop users who have the 15mL bottles labeled as 4% pilocarpine hydrochloride. People with the product are most at risk.
Check for 15mL bottles labeled 4% pilocarpine hydrochloride eye drops (Rx only). All products are affected regardless of lot number or NDC.
Look for 15mL bottles labeled 4% pilocarpine hydrochloride eye drops (Rx only).
The recall states the manufacturer went out of business and can no longer test stability, so safety cannot be guaranteed.
The recall does not specify a return process, so no action is required beyond checking the product.
All products are affected, so any 15mL bottle labeled 4% pilocarpine hydrochloride eye drops (Rx only) is included.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0862-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0862-2023 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.
