Teva Paliperidone Tablets Recall: Failed Dissolution Test Risk
Teva recalls 3mg Paliperidone Extended-Release Tablets due to potential drug release issues found in stability testing. Affected lots may have tablets that don't dissolve properly.
Lower-risk recall
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
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What happened, in plain English
Teva is recalling 3 mg Paliperidone Extended-Release Tablets because routine testing found one tablet didn't dissolve properly. This could mean other tablets in the batch might also have issues, potentially affecting how the medication works. Read more at govinfonow.com/recall/41592-teva-paliperidone-tablets-recall-failed-dissolution-test-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41592-teva-paliperidone-tablets-recall-failed-dissolution-test-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0960-2017
Cite this page
“Teva Paliperidone Tablets Recall: Failed Dissolution Test Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41592-teva-paliperidone-tablets-recall-failed-dissolution-test-risk. Based on FDA recall #D-0960-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0960-2017%22&limit=1).
Why it’s dangerous
The drug release test showed one tablet didn't dissolve as expected during stability testing. Teva warns that additional tablets in the batch might also be below specification, which could affect the medication's effectiveness.
Who’s affected
Prescription patients who received the recalled 3 mg Paliperidone Extended-Release Tablets from Actavis Laboratories FL, Inc. in Fort Lauderdale, FL. Those with mental health conditions requiring this medication are most at risk.
How to tell if you have this one
Check for 3 mg Paliperidone Extended-Release Tablets in 90-count bottles with NDC 0591-3693-19, manufactured by Actavis Laboratories FL, Inc. in Fort Lauderdale, FL, and distributed by Actavis Pharma, Inc. in Parsippany, NJ.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Medication Details
Look for the NDC code 0591-3693-19 on the bottle label to confirm it's the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this medication dangerous?
The recall is due to potential issues with drug release in stability testing, but Teva states it's not a safety hazard that could cause serious injury.
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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-0960-2017 (May 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0960-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.