Sabril (vigabatrin) oral solution recalled for cross-contamination
Lundbeck LLC recalls Sabril (vigabatrin) oral solution nationwide due to potential cross-contamination. The recall affects 10,543 cartons.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III recall, which typically indicates lower risk. The recall concerns potential cross-contamination with unspecified products, and no illnesses or injuries have been reported. This classification fits the 'precautionary recalls' category.
Plain-English summary
Lundbeck LLC is recalling Sabril (vigabatrin) 500 mg oral solution nationwide due to potential cross-contamination with other products. The recall affects 10,543 cartons.
The affected product is manufactured by Patheon in Cincinnati, Ohio (NDC 67386-211-65). The following lot numbers are included in the recall: Lots 3207333A and 3207334A (Exp. 03/2027), and Lots 3214707A, 3214709A, and 3214710A (Exp. 02/2028).
Vigabatrin is a prescription medication used to treat seizures.
The recalled product
- Product
- SABRIL (VIGABATRIN)
- Brand
- SABRIL
- Manufacturer
- Lundbeck LLC
- Category
- Drug
- Hazard
- Affected units
- 10,543
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 (7)
- Lot#: 3207333A
- 3207334A
- Exp 03/2027
- 3214707A
- 3214709A
- 3214710A
- Exp 02/2028 .
Distribution
Distributed nationwide across the United States.
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