CLASS II Drug recall · Reported 12 Sep 2018 · FDA Enforcement Report
Ethosuximide Capsules, USP, 250 mg recalled by Akorn
Akorn is recalling Ethosuximide Capsules, USP, 250 mg per, distributed nationwide in the US. The recall was initiated on 24 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1183-2018
- FDA event ID
- 80880
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2018
- FDA classified
- 7 Sep 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Aug 2018 | Recall initiated by company | |
| 7 Sep 2018 | Classified by FDA | +14 days |
| 12 Sep 2018 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Which lots are affected?
Lots: 1165280100, 1165280101, EXP 3/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Ethosuximide recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethosuximide Oral Solution USP 250 mg recalled by PAI HoldingsEthosuximide | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | ethosuximide capsules, USP, 250 mg recalled by Pfizer | Pfizer | Other | Nationwide |
| Drug | CLASS III | Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl recalled by PfizerZarontin | Pfizer | Other | Nationwide |