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Drug recall · FDA · Published November 20, 2017

Zydus Pharmaceuticals USA Inc recalls Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC

Zydus Pharmaceuticals USA recalls 30mg Paroxetine tablets due to presence of Risperidone tablets in some bottles. This could cause unintended medication intake. Return or contact for remedy.

🇺🇸 FDA recall #D-0101-2018DrugZydus Pharmaceuticals ›
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Contact the company & request your remedy

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.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Zydus Pharmaceuticals USA is recalling certain Paroxetine tablets (30mg) because Risperidone tablets were found inside some bottles. This could lead to taking the wrong medication if someone opens the bottle without checking. Read more at govinfonow.com/recall/41045-zydus-paroxetine-tablets-recall-foreign-risperidone-tablets-found.

Source Summary by GovInfoNow · govinfonow.com/recall/41045-zydus-paroxetine-tablets-recall-foreign-risperidone-tablets-found · Updated October 7, 2026 · FDA enforcement record: FDA #D-0101-2018

Cite this page

“Zydus Paroxetine Tablets Recall: Foreign Risperidone Tablets Found.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41045-zydus-paroxetine-tablets-recall-foreign-risperidone-tablets-found. Based on FDA recall #D-0101-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0101-2018%22&limit=1).

Why it’s dangerous

The recall is for Paroxetine tablets that contain Risperidone tablets inside the bottle. This means someone might accidentally take the Risperidone tablets instead of the intended Paroxetine tablets, leading to unintended medication intake.

Who’s affected

People who own or use the recalled Paroxetine tablets (30mg) from Zydus Pharmaceuticals USA. Those who take the medication as prescribed are most at risk if they accidentally ingest the foreign tablets.

How to tell if you have this one

Check for bottles labeled 'Paroxetine Tablets USP, 30 mg' with NDC numbers 68382-099-06 (30 count), 68382-099-05 (500 count), or 68382-099-10 (1000 count). These were manufactured by Cadila Healthcare Ltd in Ahmedabad, India and distributed by Zydus Pharmaceuticals USA.

  • Brand
    Zydus Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottles

    Look for bottles labeled 'Paroxetine Tablets USP, 30 mg' with NDC numbers 68382-099-06, 68382-099-05, or 68382-099-10.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

Risperidone tablets were found inside some bottles of Paroxetine tablets, which could lead to unintended medication intake.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact Zydus Pharmaceuticals USA for instructions.

Are there any safety risks?

The recall is for a low-risk situation where the foreign tablets could be accidentally taken, but the remedy is not specified in the record.

Take action

Contact Zydus Pharmaceuticals

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

Subject: Recall D-0101-2018 — Zydus Pharmaceuticals Zydus Pharmaceuticals

Hello,

I own a Zydus Pharmaceuticals that is covered by recall D-0101-2018 from Zydus Pharmaceuticals.

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-0101-2018 (November 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0101-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 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