Akorn, Inc. recalls Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use
Akorn recalls Gabapentin Oral Solution (250mg/5mL) for potential impurities that could cause serious injury. This product is for institutional use only and requires immediate action.
Stop using this now
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Gabapentin Oral Solution for possible impurities that could cause serious injury. This medication is only for institutional use and must be stopped immediately. Read more at govinfonow.com/recall/36493-akorn-gabapentin-oral-solution-recall-impurities-risk-serious-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/36493-akorn-gabapentin-oral-solution-recall-impurities-risk-serious-injury · Updated October 4, 2026 · FDA enforcement record: FDA #D-0301-2021
Cite this page
“Akorn Gabapentin Oral Solution Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36493-akorn-gabapentin-oral-solution-recall-impurities-risk-serious-injury. Based on FDA recall #D-0301-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0301-2021%22&limit=1).
Why it’s dangerous
The product failed stability testing due to an unknown impurity that could cause serious injury. This impurity was detected during 6-month testing but the exact risk mechanism is not specified.
Who’s affected
Institutional users and healthcare facilities that have this specific Gabapentin Oral Solution product. Patients receiving this medication through institutional channels are most at risk.
How to tell if you have this one
Look for the product labeled 'Gabapentin Oral Solution, 250 mg/5 mL' with four unit dose cups per tray. Check the NDC numbers: 50383-311-07 for the tray and unit dose cups. The product was manufactured in specific lots with expiration dates through May 2021 to April 2022.
- Brand
Akorn- Category
Drug
What to do — step by step
Stop Using Immediately
Discard all units of the recalled Gabapentin Oral Solution as it poses a serious injury risk.
Questions people ask
Is this product safe to use?
No, the product has failed stability testing and contains an unknown impurity that could cause serious injury. Do not use.
What is the expiration date for the recalled product?
The recalled product has expiration dates ranging from May 2021 to April 2022 depending on the lot.
Who should contact for more information?
Contact Akorn, Inc. directly for further assistance with this recall.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0301-2021 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0301-2021 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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Where this comes from
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.
- Official source: FDA Recall #D-0301-2021 (March 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0301-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.