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Drug recall · FDA · Published August 19, 2016

Impax Laboratories, Inc. recalls Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only,

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

🇺🇸 FDA recall #D-0215-2017DrugImpax Laboratories, Inc. ›
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Recalling firmImpax Laboratories, Inc.31153 San Antonio Street, N/A · Hayward, CA 94544
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.
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Source Page by GovInfoNow · govinfonow.com/recall/42482-impax-laboratories-inc-recalls-lamotrigine-orally-disintegrating-tablets-odt-200 · Recall date August 19, 2016 · FDA enforcement record: FDA #D-0215-2017

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“Impax Laboratories, Inc. recalls Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only,.” GovInfoNow, recall dated August 19, 2016. https://govinfonow.com/recall/42482-impax-laboratories-inc-recalls-lamotrigine-orally-disintegrating-tablets-odt-200. Based on FDA recall #D-0215-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0215-2017%22&limit=1).

How to tell if you have this one

  • Brand
    Impax Laboratories, Inc.
  • Category
    Drug
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Contact Impax Laboratories, Inc.

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

Subject: Recall D-0215-2017 — Impax Laboratories, Inc. Impax Laboratories, Inc. recalls Lamotrigine Orally Disintegrating Tablets

Hello,

I own a Impax Laboratories, Inc. recalls Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, that is covered by recall D-0215-2017 from Impax Laboratories, Inc..

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-0215-2017 (August 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0215-2017 to see it in context.
  • 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