Paliperidone Extended-Release Tablets — Class I drug recall D-0960-2017
Terminated recall by Teva Pharmaceuticals, reported 2017-07-19, distributed nationwide. Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing
| Recall number | D-0960-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals, Horsham, PA, United States |
| Recall initiated | 2017-05-31 |
| Classified | 2017-07-11 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 360 bottles |
| Reason classes | specification failure |
| NDC | 00591-3693-19 |
| Lot numbers | 06/18, 1160682A |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0960-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.