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.
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 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
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Anticonvulsant
- 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
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 →Related recalls
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Similar recalls
- HighLithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion
FDA (Drugs) · 2024-01-03
- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateChlorthalidone Tablets Recalled for Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- HighDrug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage
FDA (Drugs) · 2024-01-03
- HighFDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- HighAmoxicillin tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03