The Recall Desk
ModerateFDA (Drugs)·D-1838-2019·Announced 2019-07-31

UCB Recalls Keppra Tablets for Failed Dissolution Specifications

UCB, Inc. is recalling 2,088 bottles of Keppra (levetiracetam) 1000 mg tablets in Tennessee due to failed dissolution specifications.

What this means for you

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 corresponds to a moderate severity level involving temporary or reversible health consequences, such as failed dissolution specifications without reported serious injury.

Plain-English summary

UCB, Inc. is recalling 2,088 bottles of Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle. The affected product is identified by Lot 908946 with an expiration date of 02/2022 and NDC 50474-597-66. The recall was initiated because the product failed to meet dissolution specifications.

The recall is limited to distribution in Tennessee (TN). The product is a prescription-only medication manufactured for UCB, Inc. in Smyrna, GA.

Consumers who have this specific lot of Keppra should contact their healthcare provider or pharmacist for guidance on returning the product or obtaining a replacement. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
KEPPRA (LEVETIRACETAM)
Brand
KEPPRA
Manufacturer
Ucb, Inc
Category
Drug — Anticonvulsant
Hazard
Affected units
2,088

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 (1)

  • Lot: 908946 Exp. 02/2022

UPCs (1)

  • 0350474595404

Distribution

Distributed in 1 state:

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