Akorn Ethosuximide Capsules Recall: Impurities May Cause Harm
Akorn recalls 250 mg Ethosuximide Capsules due to unspecified impurities that may cause harm. Rx-only medication with NDC 61748-025-01, lots 1165280100-1165280101, expiring 3/2019.
Recall notice
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Contact the company
What happened, in plain English
Akorn is recalling Ethosuximide Capsules (250 mg, 100 capsules per bottle) because they contain impurities that may cause harm. This medication is prescription-only and was manufactured by Swiss Caps AG in Switzerland. The recall affects specific batches with NDC 61748-025-01 and expiration dates of 3/2019. Read more at govinfonow.com/recall/39682-akorn-ethosuximide-capsules-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/39682-akorn-ethosuximide-capsules-recall-impurities-may-cause-harm · Updated October 6, 2026 · FDA enforcement record: FDA #D-1183-2018
Cite this page
“Akorn Ethosuximide Capsules Recall: Impurities May Cause Harm.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39682-akorn-ethosuximide-capsules-recall-impurities-may-cause-harm. Based on FDA recall #D-1183-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1183-2018%22&limit=1).
Why it’s dangerous
The capsules failed impurities and degradation specifications, meaning they contain substances that are not supposed to be present. This could potentially cause harm to patients taking the medication, though the exact risk is not specified in the recall notice.
Who’s affected
Prescription patients who have the specific batch of Ethosuximide Capsules with NDC 61748-025-01 and expiration date 3/2019 are affected. Patients using this medication should check their bottle's lot number and expiration date.
How to tell if you have this one
Check the product label for the NDC code 61748-025-01 and lot numbers 1165280100 or 1165280101. The expiration date on the bottle is 3/2019.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 61748-025-01 and lot numbers 1165280100 or 1165280101 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-1183-2018 (August 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1183-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.