# FDA recall D-097-2013

> **Genentech, Inc.** · Class III · drug recall initiated 2012-09-27.

## Product

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA  94080.

## Reason for recall

Short Fill: some bottles contained less than 120-count per labeled claim.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-097-2013
- **Recalling firm:** Genentech, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-27
- **Report date:** 2012-12-26
- **Termination date:** 2014-11-20

- **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-097-2013

## Citation

> AI Analytics. FDA recall D-097-2013. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-097-2013. Source: US FDA. Licensed CC0.

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