# FDA recall D-0097-2019

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2018-08-06.

## Product

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), 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.

## Distribution

Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

## Key facts

- **Recall number:** D-0097-2019
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-06
- **Report date:** 2018-10-31
- **Termination date:** 2020-02-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2019

## Citation

> AI Analytics. FDA recall D-0097-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0097-2019. Source: US FDA. Licensed CC0.

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