Akorn recalls Gabapentin Oral Solution with unapproved active ingredient
Akorn recalls 470mL amber Gabapentin Oral Solution (Rx only) due to unapproved active ingredient in manufacturing. Consumers should contact Akorn for details.
Recall notice
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Contact the company
What happened, in plain English
Akorn is recalling a specific 470mL amber-colored Gabapentin Oral Solution (250 mg/5 mL) because it was made with an unapproved active ingredient. This could pose a safety risk to people using the medication. Read more at govinfonow.com/recall/41013-akorn-recalls-gabapentin-oral-solution-with-unapproved-active-ingredient.
Source Summary by GovInfoNow · govinfonow.com/recall/41013-akorn-recalls-gabapentin-oral-solution-with-unapproved-active-ingredient · Updated October 7, 2026 · FDA enforcement record: FDA #D-0211-2018
Cite this page
“Akorn recalls Gabapentin Oral Solution with unapproved active ingredient.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41013-akorn-recalls-gabapentin-oral-solution-with-unapproved-active-ingredient. Based on FDA recall #D-0211-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0211-2018%22&limit=1).
Why it’s dangerous
The product was made with an unapproved active ingredient due to manufacturing errors. This could mean the medication is not safe or effective for patients, potentially causing health issues.
Who’s affected
People who have the specific 470mL amber bottle of Gabapentin Oral Solution (Rx only) from Hi-Tech Pharmacal Co., Inc. in Amityville, NY. Those using prescription gabapentin for conditions like nerve pain or seizures are most at risk.
How to tell if you have this one
Check for a 470mL amber-colored bottle labeled 'Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL)' with NDC 50383-311-47 and batch number 359774. This product was sold in the U.S. by Hi-Tech Pharmacal Co., Inc. in Amityville, NY.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 50383-311-47 and batch number 359774 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0211-2018 (December 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0211-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.