Data Foundry

Drug recalls 2018

Ethosuximide Capsules — Class II drug recall D-1183-2018

Terminated recall by Akorn, Inc., reported 2018-09-12, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.

Recall numberD-1183-2018
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAkorn, Inc., Lake Forest, IL, United States
Recall initiated2018-08-24
Classified2018-09-07
Reported by FDA2018-09-12
Terminated2020-11-06
DistributedNationwide (US)
Reason classesspecification failure
NDC61748-0025-01
Lot numbers1165280100, 1165280101
Expiration dates2019-03

Product

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

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1183-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.