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.
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 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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