Akorn Recalls Ethosuximide Capsules Due to Impurity Failures
Akorn, Inc. is recalling Ethosuximide Capsules, 250 mg, due to out-of-specification results for an unspecified impurity.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the impurity is unspecified, fitting the criteria for a moderate severity rating.
Plain-English summary
Akorn, Inc. is recalling Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle (NDC: 61748-025-01). The recall involves 23,788 bottles distributed nationwide in the USA. The affected lots are 1165280100 and 1165280101, with an expiration date of 3/2019.
The recall was initiated because the product failed impurities/degradation specifications, specifically yielding out-of-specification (OOS) results for an unspecified impurity. The capsules were manufactured for VersaPharm Incorporated and by Swiss Caps AG.
Consumers and healthcare providers should check their inventory for the specific NDC and lot numbers listed above. If the product matches the recalled items, it should be discontinued and returned to the pharmacy or supplier for replacement or refund.
The recalled product
- 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
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Anticonvulsant
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: 1165280100
- 1165280101
- EXP 3/2019
Distribution
Distributed nationwide across the United States.
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