CLASS II Drug recall · Reported 18 May 2016 · FDA Enforcement Report
Paliperidone Extended-release Tablets, 5 mg recalled
Mylan Pharmaceuticals is recalling Paliperidone Extended-release Tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 12 Feb 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0840-2016
- FDA event ID
- 73671
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2016
- FDA classified
- 6 May 2016
- Reported
- 18 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 12 Feb 2016 | Recall initiated by company | |
| 6 May 2016 | Classified by FDA | +84 days |
| 18 May 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications; three month stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Where it was distributed
Nationwide
Questions about this recall
Is Paliperidone Extended-release Tablets, 5 mg recalled?
Yes. Mylan Pharmaceuticals recalled Paliperidone Extended-release Tablets, 5 mg on 12 Feb 2016. The recall is Class II and its status is Terminated. Recall number D-0840-2016.
Why was it recalled?
Failed Dissolution Specifications; three month stability time point.
Which lots are affected?
Lot: 2005441, 01/2017, Code: 0378-3978-93
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Paliperidone recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paliperidone Extended-release Tablets, 9 mg per carton recalledPaliperidone | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Paliperidone Extended Release Tablets 3 mg recalled | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
| Drug | CLASS II | Paliperidone Extended Release Tablets 9 mg recalled | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
| Drug | CLASS I | Paliperidone Extended-Release Tablets, 3 mg recalled | Teva Pharmaceuticals | Potency & Assay | Nationwide |