# FDA recall D-0960-2017

> **Teva Pharmaceuticals** · Class I · drug recall initiated 2017-05-31.

## 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.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0960-2017
- **Recalling firm:** Teva Pharmaceuticals
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-31
- **Report date:** 2017-07-19
- **Termination date:** 2018-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0960-2017

## Citation

> AI Analytics. FDA recall D-0960-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0960-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*