# FDA recall D-0357-2021

> **Genentech Inc** · Class III · drug recall initiated 2021-04-20.

## Product

Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05

## Reason for recall

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

## Distribution

Distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0357-2021
- **Recalling firm:** Genentech Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-20
- **Report date:** 2021-05-05
- **Termination date:** 2022-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0357-2021

## Citation

> AI Analytics. FDA recall D-0357-2021. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0357-2021. Source: US FDA. Licensed CC0.

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