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Drug recall · FDA · Published January 14, 2016

Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd.,

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

🇺🇸 FDA recall #D-0725-2016DrugZydus Pharmaceuticals (USA) Inc ›
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Recalling firmZydus Pharmaceuticals USA Inc73 Route 31 N, N/A · Pennington, NJ 08534-3601
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/43268-zydus-pharmaceuticals-usa-inc-recalls-risperidone-orally-disintegrating-tablets-2 · Recall date January 14, 2016 · FDA enforcement record: FDA #D-0725-2016

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“Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd.,.” GovInfoNow, recall dated January 14, 2016. https://govinfonow.com/recall/43268-zydus-pharmaceuticals-usa-inc-recalls-risperidone-orally-disintegrating-tablets-2. Based on FDA recall #D-0725-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0725-2016%22&limit=1).

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  • Brand
    Zydus Pharmaceuticals (USA) Inc
  • Category
    Drug
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Contact Zydus Pharmaceuticals (USA) Inc

We’ve drafted a message you can send Zydus Pharmaceuticals (USA) Inc to request your refund or repair — edit it as you like.

Subject: Recall D-0725-2016 — Zydus Pharmaceuticals (USA) Inc Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRA

Hello,

I own a Zydus Pharmaceuticals USA Inc recalls risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., that is covered by recall D-0725-2016 from Zydus Pharmaceuticals (USA) Inc.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0725-2016 (January 14, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0725-2016 to see it in context.
  • 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