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Drug recall · FDA · Published November 17, 2023

InvaGen Pharmaceuticals, Inc. recalls Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen

InvaGen Pharmaceuticals recalls Vigabatrin oral solution due to risk of powder leaking from pouches. This medication is prescription-only and may cause ineffective treatment if powder leaks.

🇺🇸 FDA recall #D-0220-2024DrugInvaGen ›
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Contact the company & request your remedy

Recalling firmInvaGen Pharmaceuticals, Inc.550 S Research Pl · Central Islip, NY 11722-4415
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

InvaGen Pharmaceuticals is recalling Vigabatrin oral solution (500 mg per packet) because the pouches may leak powder. This could lead to ineffective treatment if the medication is not properly administered. Read more at govinfonow.com/recall/32944-invagen-vigabatrin-oral-solution-recall-leaking-powder-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32944-invagen-vigabatrin-oral-solution-recall-leaking-powder-hazard · Updated September 23, 2026 · FDA enforcement record: FDA #D-0220-2024

Cite this page

“InvaGen Vigabatrin Oral Solution Recall: Leaking Powder Hazard.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32944-invagen-vigabatrin-oral-solution-recall-leaking-powder-hazard. Based on FDA recall #D-0220-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0220-2024%22&limit=1).

Why it’s dangerous

The pouches in the medication may leak powder, which could lead to inconsistent dosing. This might result in ineffective treatment for patients using the medication as prescribed.

Who’s affected

Prescription patients using Vigabatrin oral solution from InvaGen. Those with specific medical conditions requiring precise dosing are most at risk.

How to tell if you have this one

Check for Vigabatrin oral solution packets labeled '500 mg per packet, 50 packets per box' manufactured by InvaGen Pharmaceuticals. The product was made in Hauppauge, NY with lot number NB301030 and expires March 31, 2025.

  • Brand
    InvaGen
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Medication

    Verify the product label matches the description: Vigabatrin oral solution, 500 mg per packet, 50 packets per box, manufactured by InvaGen Pharmaceuticals.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a potential risk of powder leaking, which could affect treatment effectiveness. Consult your doctor if you have concerns.

How can I get a replacement?

The recall record does not specify a replacement or remedy.

What should I do if I have this product?

The recall record does not provide specific instructions for action beyond checking the product label.

Take action

Contact InvaGen

We’ve drafted a message you can send InvaGen to request your refund or repair — edit it as you like.

Subject: Recall D-0220-2024 — InvaGen InvaGen

Hello,

I own a InvaGen that is covered by recall D-0220-2024 from InvaGen.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0220-2024 (November 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0220-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA