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Drug recall · FDA · Published September 11, 2018

Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT

Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.

🇺🇸 FDA recall #D-1204-2018DrugTorrent Pharma Inc. ›
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Recalling firmTorrent Pharma Inc.1803 Whites Rd Ste 1, N/A · Kalamazoo, MI 49008-2883
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/39571-torrent-pharma-inc-recalls-lamotrigine-extended-release-tablets-usp-200 · Recall date September 11, 2018 · FDA enforcement record: FDA #D-1204-2018

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“Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT.” GovInfoNow, recall dated September 11, 2018. https://govinfonow.com/recall/39571-torrent-pharma-inc-recalls-lamotrigine-extended-release-tablets-usp-200. Based on FDA recall #D-1204-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1204-2018%22&limit=1).

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  • Brand
    Torrent Pharma Inc.
  • Category
    Drug
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Contact Torrent Pharma Inc.

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

Subject: Recall D-1204-2018 — Torrent Pharma Inc. Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 

Hello,

I own a Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT that is covered by recall D-1204-2018 from Torrent Pharma 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-1204-2018 (September 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1204-2018 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