Zydus Recalls Risperidone Tablets Due to Impurity Issues
Zydus Pharmaceuticals recalls specific lots of risperidone orally disintegrating tablets due to failed impurity specifications. Check your bottle's lot number.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
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What happened, in plain English
Zydus Pharmaceuticals USA Inc is recalling one lot of risperidone orally disintegrating tablets, 2 mg, in 30-count bottles. The recall was initiated because the product failed to meet specifications for a known degradant (impurity). This specific batch has an expiration date of April 2016. Read more at govinfonow.com/recall/43268-zydus-recalls-risperidone-tablets-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/43268-zydus-recalls-risperidone-tablets-due-to-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0725-2016
Cite this page
“Zydus Recalls Risperidone Tablets Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43268-zydus-recalls-risperidone-tablets-due-to-impurity-issues. Based on FDA recall #D-0725-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0725-2016%22&limit=1).
Why it’s dangerous
The tablets contain out-of-specification levels of a known degradant. While the record does not specify the exact health effects of this impurity, failing impurity specifications means the drug's potency or safety profile may be compromised compared to labeled standards.
Who’s affected
Patients currently taking risperidone orally disintegrating tablets who purchased the recalled lot. Individuals with this prescription or those holding the specific bottle identified in the recall are at risk of receiving a product that does not meet quality standards.
How to tell if you have this one
Check your medication bottle for NDC 68382-156-06 and Lot # MP4967. The product is risperidone orally disintegrating tablets, 2 mg, in 30-count bottles. It was distributed nationwide in the US including Puerto Rico.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle has NDC 68382-156-06 and Lot # MP4967 with an expiry of 04/2016.
Contact your pharmacist
Speak with your healthcare provider or pharmacist to discuss alternative treatment options if you have the recalled lot.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide including Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- 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-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.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.