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# InvaGen Pharma Recalls Vigabatrin Lot
- URL: https://www.fdaweb.com/invagen-pharma-recalls-vigabatrin-lot/
- Published: 2023-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:18:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155965

Cipla’s InvaGen Pharmaceuticals unit has recalled one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues that could allow powder leakage from the pouch. “An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing,” a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/invagen-pharmaceuticals-issues-voluntary-nationwide-recall-vigabatrin-oral-solution-usp-500mg-due?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. Inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention, it adds. To date, the company says it has not received any reports of adverse events related to the recall.

Vigabatrin is used for treating refractory complex partial seizures in patients two years of age and older who have responded adequately to several alternative treatments. The drug is packaged in foil pouches, each containing 500mg of vigabatrin. The affected lot is # NB301030, with an expiration date of 03/2025.