Mylan Paliperidone Recall: Failed Dissolution Specs
Mylan recalls 1.5 mg Paliperidone extended-release tablets due to failed dissolution specifications. Check lot numbers and NDC for details.
Use caution until it’s fixed
Failed Dissolution Specifications; three month stability time point.
Contact the company
What happened, in plain English
Mylan Pharmaceuticals Inc. is recalling specific bottles of Paliperidone Extended-release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point. This means the medication may not release or absorb as intended, potentially affecting its efficacy. The recall affects 2,928 bottles distributed nationwide. Read more at govinfonow.com/recall/43145-mylan-paliperidone-recall-failed-dissolution-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/43145-mylan-paliperidone-recall-failed-dissolution-specs · Updated October 11, 2026 · FDA enforcement record: FDA #D-0840-2016
Cite this page
“Mylan Paliperidone Recall: Failed Dissolution Specs.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43145-mylan-paliperidone-recall-failed-dissolution-specs. Based on FDA recall #D-0840-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0840-2016%22&limit=1).
Why it’s dangerous
The tablets failed to meet dissolution specifications at a three-month stability time point. This defect could result in the drug not being released from the tablet properly, which might lead to inconsistent dosing and reduced therapeutic effect for the patient.
Who’s affected
Patients currently taking Paliperidone Extended-release Tablets, 1.5 mg, prescribed by a doctor and who possess the specific recalled lots are affected. These individuals may be receiving medication that does not meet quality standards for dissolution.
How to tell if you have this one
Look for Paliperidone Extended-release Tablets, 1.5 mg, in 30 count bottles. Check for NDC 0378-3978-93 and Lot number 2005441 with Code 0378-3978-93. The product is Rx only.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches NDC 0378-3978-93 and Lot 2005441.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider about replacing the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
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 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0840-2016 (February 12, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0840-2016 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.