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Lower risk Drug recall · FDA · Published September 4, 2019

Jubilant Cadista recalls Pantoprazole 40mg tablets with dark brown discoloration

Jubilant Cadista recalls 40mg Pantoprazole tablets with dark brown discoloration on edges. This CGMP deviation may affect product quality but does not indicate immediate safety risks.

🇺🇸 FDA recall #D-0145-2020DrugJubilant Cadista ›
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Recalling firmJubilant Cadista Pharmaceuticals, Inc.207 Kiley Dr · Salisbury, MD 21801-2249
✎ GovInfoNow plain-language explainer

What happened, in plain English

Jubilant Cadista is recalling 40mg Pantoprazole Sodium Delayed Release Tablets that show dark brown discoloration on tablet edges. This issue stems from a manufacturing deviation that could affect product quality but does not pose immediate safety risks. Read more at govinfonow.com/recall/38025-jubilant-cadista-recalls-pantoprazole-40mg-tablets-with-dark-brown-discoloration.

Source Summary by GovInfoNow · govinfonow.com/recall/38025-jubilant-cadista-recalls-pantoprazole-40mg-tablets-with-dark-brown-discoloration · Updated October 5, 2026 · FDA enforcement record: FDA #D-0145-2020

Cite this page

“Jubilant Cadista recalls Pantoprazole 40mg tablets with dark brown discoloration.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38025-jubilant-cadista-recalls-pantoprazole-40mg-tablets-with-dark-brown-discoloration. Based on FDA recall #D-0145-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2020%22&limit=1).

Why it’s dangerous

The tablets show dark brown discoloration on their edges due to a manufacturing deviation. This indicates a potential issue with the product's quality but does not mean the tablets are unsafe or cause harm when taken as directed.

Who’s affected

Prescription patients who received the recalled 40mg Pantoprazole tablets with dark brown discoloration on edges. Those most at risk are patients using the product for acid reflux or ulcers.

How to tell if you have this one

Check for dark brown discoloration on the edges of 40mg Pantoprazole tablets in 90-count bottles. The product was manufactured by Jubilant Generics Ltd in India and marketed by Jubilant Cadista Pharmaceuticals Inc. in the US.

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

What to do — step by step

  1. Check for discoloration

    Inspect the tablets for dark brown discoloration on the edges. If present, do not use the product.

Where it went and when

Where it was distributed

Distributed in 4 states and Puerto Rico.

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: yesRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: 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: yesMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Mississippi, Ohio, Puerto Rico, Rhode Island, Tennessee.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Sep 4, 201912. FDA classified it Class II: Oct 17, 201923. Published in FDA’s Enforcement Report: Oct 23, 201934. FDA terminated the recall: Feb 12, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  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-0145-2020 (September 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0145-2020 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