Paliperidone Extended Release Tablets 3 mg — Class II drug recall D-0096-2019
Terminated recall by Teva Pharmaceuticals USA, reported 2018-10-31, distributed nationwide. Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might
| Recall number | D-0096-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-08-06 |
| Classified | 2018-10-25 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 27,816 bottles |
| NDC | 00591-3693-30 |
| Expiration dates | 2019-03, 2019-09, 2019-10, 2020-01 |
Product
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Reason for recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
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-0096-2019. 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.