CLASS I Drug recall · Reported 17 Jan 2024 · FDA Enforcement Report
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalled
InvaGen Pharmaceuticals is recalling Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per, distributed nationwide in the US. The recall was initiated on 17 Nov 2023 and the FDA has classified it as Class I.
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-0220-2024
- FDA event ID
- 93422
- Recalling firm
- InvaGen Pharmaceuticals, Central Islip, NY
- Brand
- Vigabatrin
- Manufacturer
- Cipla USA, Inc.
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 17 Nov 2023
- FDA classified
- 8 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 17 Nov 2023 | Recall initiated by company | |
| 8 Jan 2024 | Classified by FDA | +52 days |
| 17 Jan 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: powder may leak out of the pouch
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Defective Container: powder may leak out of the pouch
Which lots are affected?
Lot #: NB301030, Exp. Date 03/31/2025
Where was it sold?
Nationwide within the United States
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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Other Vigabatrin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets recalledSabril | Lundbeck | Other | Nationwide |