FDA Drug recall D-1142-2023
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
- FDA Drug
- Class III
- completed
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class III recall of Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65 by Lundbeck, citing cross contamination with other products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1142-2023 |
| Classification | Class III |
| Status | completed |
| Initiated | 2023-08-17 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lundbeck |
| Distribution | US |
Product
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Reason
Cross contamination with other products
Identifiers
| ndc | 67386-211-65 |
|---|---|
| code_info | Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 . |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1142-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.