Torrent Lamotrigine Extended-Release Tablets Recall: Failed Dissolution Test
Torrent Pharma recalls 200 mg Lamotrigine Extended-Release Tablets due to failed dissolution test during stability testing. This may affect medication effectiveness. Check NDC 13668-342-30 and lot BFR5D002.
Lower-risk recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Contact the company
What happened, in plain English
Torrent Pharma is recalling 200 mg Lamotrigine Extended-Release Tablets because they failed dissolution testing. This could mean the medication doesn't work properly. Patients with seizures or other conditions requiring this drug should contact their doctor. Read more at govinfonow.com/recall/39571-torrent-lamotrigine-extended-release-tablets-recall-failed-dissolution-test.
Source Summary by GovInfoNow · govinfonow.com/recall/39571-torrent-lamotrigine-extended-release-tablets-recall-failed-dissolution-test · Updated October 6, 2026 · FDA enforcement record: FDA #D-1204-2018
Cite this page
“Torrent Lamotrigine Extended-Release Tablets Recall: Failed Dissolution Test.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39571-torrent-lamotrigine-extended-release-tablets-recall-failed-dissolution-test. Based on FDA recall #D-1204-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1204-2018%22&limit=1).
Why it’s dangerous
The tablets failed a dissolution test during stability testing, meaning they may not release medication properly in the body. This could lead to inconsistent drug levels and potential treatment failure. However, the test was done in a lab setting, not real-world use.
Who’s affected
People with prescriptions for Lamotrigine Extended-Release Tablets who received this specific batch from Torrent Pharma. Those with seizure disorders or other conditions requiring this medication are most at risk.
How to tell if you have this one
Check for NDC code 13668-342-30 and lot number BFR5D002 on the bottle. The product was manufactured in India and sold under the brand name TORRENT.
- Brand
Torrent- Category
Drug
What to do — step by step
Check Medication Details
Look for NDC 13668-342-30 and lot BFR5D002 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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.
- Plain-language summary written by qwen3:4b on October 6, 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.