FDA Drug recall D-097-2013
CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05
- FDA Drug
- Class III
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class III recall of CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05 by Genentech, citing short Fill: some bottles contained less than 120-count per labeled claim.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-097-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-09-27 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Genentech |
| Distribution | US |
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
Short Fill: some bottles contained less than 120-count per labeled claim.
Identifiers
| code_info | Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-097-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.