Akorn recalls all 2mg/5mL oral solution bottles due to inability to conduct stability studies after company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all Trihexyphenidyl Hydrochloride Oral Solution bottles because the manufacturer went out of business and can no longer perform stability testing. This means the medication may not be safe for long-term use.
The manufacturer went out of business and can no longer conduct stability studies. This means the medication's safety and effectiveness over time cannot be confirmed. Without stability testing, the medication might degrade or become unsafe.
Prescription medication users who have the 473 mL bottles of Trihexyphenidyl Hydrochloride Oral Solution. People with this medication are at risk if they need long-term stability testing.
Check for 473 mL bottles labeled 'Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL' with prescription-only status. All lots and all National Drug Codes (NDCs) are affected.
Look for the product name and size on the bottle label to confirm it matches the recalled items.
The manufacturer went out of business and can no longer conduct stability studies, which means the medication's safety and effectiveness over time cannot be confirmed.
The recall record does not specify a remedy.
Check for 473 mL bottles labeled 'Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL' with prescription-only status. All lots and all National Drug Codes (NDCs) 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-0852-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0852-2023 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.
