Akorn recalls all Lactulose Solution bottles due to company closure halting stability testing. No immediate risk but products may degrade over time.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Lactulose Solution products (15mL, 30mL, 473mL, and 946mL bottles) because the company went out of business and can no longer perform stability tests. This means the products might degrade over time, though there's no immediate risk of injury.
The company went out of business and stopped conducting stability studies. This means the product's quality and safety could degrade over time, but there's no immediate risk of injury or illness.
People who have Lactulose Solution bottles from Akorn, Inc. (Rx only) are affected. Those using the product for medical purposes may be at slightly higher risk if the solution degrades.
Check for Akorn, Inc. Lactulose Solution bottles labeled 10g/15mL in 15mL, 30mL, 473mL, or 946mL sizes. All products were distributed by Akorn, Inc. in Gurnee, IL.
Look for Akorn, Inc. Lactulose Solution bottles with 10g/15mL concentration in 15mL, 30mL, 473mL, or 946mL sizes.
No immediate risk of injury or illness, but the product may degrade over time due to the company no longer performing stability tests.
The recall doesn't require discarding the product; it's a low-risk situation where the product might degrade over time.
Check for Akorn, Inc. Lactulose Solution bottles labeled 10g/15mL in 15mL, 30mL, 473mL, or 946mL sizes.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0814-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0814-2023 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.
