The Recall Desk
ModerateFDA (Drugs)·D-0589-2021·Announced 2021-06-02

Cardinal Health Recalls VIMPAT Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 796 bottles of VIMPAT (lacosamide) 100 mg tablets due to intermittent temperature excursions during storage.

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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a storage condition deviation (temperature excursion) rather than a confirmed contamination or defect causing injury.

Plain-English summary

Cardinal Health Inc. is recalling 796 bottles of VIMPAT (lacosamide) 100 mg tablets, 60-count bottles. The product is prescription-only and was manufactured for UCB, Inc. in Smyrna, GA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product code is 912056.

The recalled product was distributed in Florida, Georgia, and South Carolina. Consumers with this product should contact their healthcare provider or pharmacist for guidance on what to do next.

The recalled product

Product
VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080
Affected units
796

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)

  • 912056

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →