CLASS III Drug recall · Reported 6 Sep 2023 · FDA Enforcement Report
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets recalled
Lundbeck is recalling Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, distributed nationwide in the US. The recall was initiated on 17 Aug 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1142-2023
- FDA event ID
- 92894
- Recalling firm
- Lundbeck, Deerfield, IL
- Brand
- Sabril
- Manufacturer
- Lundbeck Pharmaceuticals LLC
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 17 Aug 2023
- FDA classified
- 29 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 17 Aug 2023 | Recall initiated by company | |
| 29 Aug 2023 | Classified by FDA | +12 days |
| 6 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products
Product as listed by the FDA
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Where it was distributed
Nationwide within the U.S.
Questions about this recall
Why was it recalled?
Cross contamination with other products
Which lots are affected?
Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
Where was it sold?
Nationwide within the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Vigabatrin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin | InvaGen Pharmaceuticals | Packaging Defects | Nationwide |