# FDA recall D-0511-2017

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2017-02-17.

## Product

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA  19454.

## Reason for recall

Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.

## Distribution

Nationwide in the United States and Puerto Rico

## Key facts

- **Recall number:** D-0511-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-17
- **Report date:** 2017-03-15
- **Termination date:** 2018-02-05

- **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-0511-2017

## Citation

> AI Analytics. FDA recall D-0511-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0511-2017. Source: US FDA. Licensed CC0.

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