CellCept — Class III drug recall D-097-2013
Terminated recall by Genentech, Inc., reported 2012-12-26, distributed nationwide. Short Fill: some bottles contained less than 120-count per labeled claim.
| Recall number | D-097-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech, Inc., South San Francisco, CA, United States |
| Recall initiated | 2012-09-27 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2014-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,128 bottles |
| Reason classes | labeling |
| NDC | 00004-0259-05, 00004-0259-51 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-097-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.