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
Hazard
  • cross-contamination

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.