FDA Drug recall D-0960-2017
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL…
- FDA Drug
- Class I
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class I recall of Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL… by Teva Pharmaceuticals, citing 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 t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0960-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-05-31 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Lot: 1160682A, EXP. 06/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0960-2017%22
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