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Stop using now Drug recall · FDA · Published October 9, 2013

Sandoz Recalls Ropinirole 2mg Tablets Due to Contamination

Sandoz recalls specific lots of Ropinirole 2mg extended-release tablets due to potential cross-contamination with mycophenolate mofetil.

🇺🇸 FDA recall #D-66458-1DrugSandoz ›
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Recalling firmSandoz, Inc506 Carnegie Ctr Ste 400 · Princeton, NJ 08540-6243
✎ GovInfoNow plain-language explainer

Sandoz, Inc. is recalling certain lots of Ropinirole Extended-Release Tablets, 2 mg, in 90-count bottles. The recall is necessary because these products may contain carryover from the previously manufactured product, mycophenolate mofetil. This cross-contamination poses a risk to patients taking this medication for Parkinson's disease or restless legs syndrome. Read more at govinfonow.com/recall/46566-sandoz-inc-recalls-ropinirole-extended-release-tablets-2-mg-90.

Source Summary by GovInfoNow · govinfonow.com/recall/46566-sandoz-inc-recalls-ropinirole-extended-release-tablets-2-mg-90 · Updated October 13, 2026 · FDA enforcement record: FDA #D-66458-1

Cite this page

“Sandoz Recalls Ropinirole 2mg Tablets Due to Contamination.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46566-sandoz-inc-recalls-ropinirole-extended-release-tablets-2-mg-90. Based on FDA recall #D-66458-1 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66458-1%22&limit=1).

Sandoz Inc. recalled Ropinirole Extended-Release Tablets, 2 mg, 90-count bottles due to potential cross-contamination with mycophenolate mofetil, the FDA announced on Oct. 9, 2013. The recall was voluntary and classified as Class II.

How to tell if you have it

  • Brand: Sandoz
  • Product: Ropinirole Extended-Release Tablets, 2 mg, 90 count bottle
  • NDC: 0781-5780-92
  • Lot code: DJ2744
  • Expiration date: 12/2014
  • Quantity: 692 bottles
  • Distribution: Nationwide

The hazard

Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.

Context

GovInfoNow's records show Sandoz Inc. has had 29 other recalls on record since Oct. 11, 2013. Recent Sandoz recalls include Focalin XR 5mg Capsules (June 1, 2026), Cyclophosphamide Injection (Sept. 5, 2025), and Ciprofloxacin Otic Suspension (Aug. 13, 2025). Other recent recalls of similar products include Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall (Nov. 21, 2025), Golden State Medical Supply Primidone Tablets Recall (April 27, 2026), and JB Chemicals Recalls Cetirizine Tablets Due to Cross-Contamination (June 24, 2026).

How to tell if you have this one

Check your bottle for the following details: Product is Ropinirole Extended-Release Tablets, 2 mg, 90 count. NDC is 0781-5780-92. Lot number is DJ2744. Expiration date is 12/2014. The product was manufactured in India by Sandoz Private Ltd for Sandoz Inc, Princeton, NJ.

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

What to do — step by step

  1. Stop taking the medication

    Do not consume any tablets from the recalled lots due to the risk of cross-contamination with mycophenolate mofetil.

  2. Contact your healthcare provider

    Speak with your doctor or pharmacist immediately to discuss alternative treatment options and proper disposal of the recalled product.

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 9 months after the firm started it.

1. Firm started the recall: Oct 9, 201312. FDA classified it Class II: Nov 4, 201323. Published in FDA’s Enforcement Report: Nov 13, 201334. FDA terminated the recall: Jul 7, 2014420132014
  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.

✎ GovInfoNow

Questions people ask

What is the NDC number for the recalled product?

The National Drug Code (NDC) for the recalled 90-count bottles is 0781-5780-92.

How many bottles are included in this recall?

A total of 692 bottles, each containing 90 tablets, are being recalled nationwide.

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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-66458-1 (October 9, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-66458-1 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 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