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Lower risk Drug recall · FDA · Published May 26, 2020

Jubilant Cadista Lamotrigine Tablets Recall: Foreign Silica Risk

Jubilant Cadista recalls 150mg Lamotrigine tablets with silica granules from desiccant packs. Foreign substance may cause injury. Check lot numbers 19P0437 & 19P0438.

🇺🇸 FDA recall #D-1281-2020DrugJubilant Cadista ›
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Recalling firmJubilant Cadista Pharmaceuticals, Inc.207 Kiley Dr · Salisbury, MD 21801-2249
✎ GovInfoNow plain-language explainer

Jubilant Cadista is recalling 150mg Lamotrigine tablets that may contain silica from desiccant packs. This foreign substance could cause injury if ingested. Affected products were shipped in bulk containers with specific lot numbers. Read more at govinfonow.com/recall/37102-jubilant-cadista-lamotrigine-tablets-recall-foreign-silica-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37102-jubilant-cadista-lamotrigine-tablets-recall-foreign-silica-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1281-2020

Cite this page

“Jubilant Cadista Lamotrigine Tablets Recall: Foreign Silica Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37102-jubilant-cadista-lamotrigine-tablets-recall-foreign-silica-risk. Based on FDA recall #D-1281-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1281-2020%22&limit=1).

Jubilant Cadista Pharmaceuticals, Inc. recalled Lamotrigine Tablets, USP, 150 mg from a 20,000-count bulk container due to foreign silica granules, the FDA said on May 26, 2020. The voluntary Class III recall affected 1,313,333 tablets distributed in Tennessee.

How to tell if you have it

  • Brand: Jubilant Cadista
  • Product: Lamotrigine Tablets, USP, 150 mg
  • Packaging: 20,000-count bulk container
  • NDC: 59746-247-97
  • Lot codes: 19P0437, 19P0438
  • Expiration date: 09/30/2021
  • Manufacturer: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
  • Repackager: AvKare Inc., Pulaski, TN
  • Distribution: Tennessee

The hazard

The recall cites the presence of foreign substances visually consistent with silica granules from desiccant packs used during storage. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Jubilant Cadista Pharmaceuticals, Inc. has had 24 other recalls since February 11, 2013. Recent brand recalls include Prochlorperazine Tablets on December 27, 2022, and Irbesartan tablets on July 18, 2022. Other recent recalls of similar products include Bionpharma Divalproex Tablets (June 26, 2026), Graviti Furosemide Tablets (January 10, 2026), and Guardian Drug CAREone Calcium Antacid (May 28, 2026).

How to tell if you have this one

Check for Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk containers. Look for lot numbers 19P0437 or 19P0438 on the packaging.

  • Brand
    Jubilant Cadista
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers 19P0437 or 19P0438 on the packaging of the Lamotrigine tablets.

Where it went and when

Where it was distributed

Distributed in Tennessee.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

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

States: Tennessee.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: May 26, 202012. FDA classified it Class III: May 29, 202023. Published in FDA’s Enforcement Report: Jun 3, 202034. FDA terminated the recall: Nov 15, 2022420202022
  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-1281-2020 (May 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1281-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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