FDA Drug recall D-0591-2021
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0591-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 50474-370-66 |
|---|---|
| ndc | 50474-470-66 |
| ndc | 50474-470-09 |
| ndc | 50474-470-14 |
| ndc | 50474-570-66 |
| ndc | 50474-570-09 |
| ndc | 50474-570-14 |
| ndc | 50474-670-66 |
| ndc | 50474-770-66 |
| ndc | 50474-770-09 |
| ndc | 50474-770-14 |
| ndc | 50474-870-15 |
| ndc | 50474-970-63 |
| ndc | 50474-970-75 |
| code_info | 309750 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0591-2021%22
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