CLASS I Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
Paliperidone Extended-Release Tablets, 3 mg recalled
Teva Pharmaceuticals is recalling Paliperidone Extended-Release Tablets, 3 mg, distributed nationwide in the US. The recall was initiated on 31 May 2017 and the FDA has classified it as Class I.
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-0960-2017
- FDA event ID
- 77393
- Recalling firm
- Teva Pharmaceuticals, Horsham, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 31 May 2017
- FDA classified
- 11 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 31 May 2017 | Recall initiated by company | |
| 11 Jul 2017 | Classified by FDA | +41 days |
| 19 Jul 2017 | Published in enforcement report | +8 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: 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.
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, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot: 1160682A, EXP. 06/18
Where was it sold?
Nationwide in the US
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Paliperidone Extended Release Tablets 9 mg recalled | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Paliperidone Extended-release Tablets, 1.5 mg recalled | Mylan Pharmaceuticals | Potency & Assay | Nationwide |