RecallRadar

FDA Drug recall D-1183-2018

Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062

On 2018-09-12 the FDA classified a Class II recall of Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062 by Akorn, citing failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1183-2018
ClassificationClass II
Statusterminated
Initiated2018-08-24
Published2018-09-12
Last updated2026-09-13 11:52 UTC
CompanyAkorn
DistributionUS

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

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

Identifiers

code_infoLots: 1165280100, 1165280101, EXP 3/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1183-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.