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Lower risk Drug recall · FDA · Published August 19, 2016

Unichem Lamotrigine Tablets 150mg Recall: Wrong Imprint Risk

Unichem Pharmaceuticals recalls 150mg Lamotrigine tablets with incorrect imprint debossed on the tablets. This could lead to confusion with other medications. Contact Unichem for details.

🇺🇸 FDA recall #D-1519-2016DrugUnichem ›
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Recalling firmUnichem Pharmaceuticals Usa Inc777 Terrace Ave, Suite 102 · Hasbrouck Heights, NJ 07604-3102
✎ GovInfoNow plain-language explainer

What happened, in plain English

Unichem Pharmaceuticals is recalling 150mg Lamotrigine tablets that have an incorrect imprint debossed on them. This could cause confusion with other medications, potentially leading to incorrect dosing. Read more at govinfonow.com/recall/42483-unichem-lamotrigine-tablets-150mg-recall-wrong-imprint-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/42483-unichem-lamotrigine-tablets-150mg-recall-wrong-imprint-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-1519-2016

Cite this page

“Unichem Lamotrigine Tablets 150mg Recall: Wrong Imprint Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42483-unichem-lamotrigine-tablets-150mg-recall-wrong-imprint-risk. Based on FDA recall #D-1519-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1519-2016%22&limit=1).

Why it’s dangerous

The tablets have an incorrect imprint debossed on them, which could lead to confusion with other medications. This might result in incorrect dosing if the tablets are mixed up with other medications.

Who’s affected

People who have the 150mg Lamotrigine tablets with the incorrect imprint debossed on them. Those who take these medications for seizures or other conditions are most at risk.

How to tell if you have this one

Check for the imprint debossed on the tablets. The product was manufactured by Unichem Laboratories LTD. in India and marketed by Unichem Pharmaceuticals (USA) in the US. The lot number is GLEH 16003, expiring 03/31/18.

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

What to do — step by step

  1. Check Imprint

    Look for the incorrect imprint debossed on the tablets to confirm if they are recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

1. Firm started the recall: Aug 19, 201612. FDA classified it Class III: Sep 23, 201623. Published in FDA’s Enforcement Report: Oct 5, 201634. FDA terminated the recall: Feb 7, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. 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-1519-2016 (August 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1519-2016 to see it in context.
  • Plain-language summary written by qwen3:4b on October 9, 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