The Recall Desk
ModerateFDA (Drugs)·D-1142-2023·Announced 2023-09-06

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.

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: 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
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.