Akorn recalls 10mL hydrocortisone and acetic acid otic solution due to stability concerns after firm went out of business. All products are affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 10 mL hydroc:ortisone and acetic acid otic solution bottles because the company went out of business and can no longer ensure product stability. This means the medication may not be safe to use as intended.
The manufacturer went out of business and can no longer conduct stability testing. This means the medication's safety and effectiveness could be compromised over time.
Prescription ear drops from Akorn, Inc. in the US. People who have received this medication from a doctor are most at risk.
Check for 10 mL bottles labeled 'Hydrocortisone and Acetic Acid Otic Solution, USP, Rx Only'. All products are affected regardless of lot number or NDC.
Look for 10 mL bottles labeled 'Hydrocortisone and Acetic Acid Otic Solution, USP, Rx Only' from Akorn, Inc.
The recall states the manufacturer went out of business and can no longer ensure stability, so the product may not be safe to use as intended.
The recall does not specify a return process, so contact your healthcare provider for guidance.
All 10 mL bottles labeled 'Hydrocortisone and Acetic Acid Otic Solution, USP, Rx Only' from Akorn, Inc. are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0810-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0810-2023 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.
