CLASS III Drug recall · Reported 26 Dec 2012 · FDA Enforcement Report
CellCept (mycophenolate mofetil) capsules, 250 mg recalled by Genentech
Genentech is recalling CellCept (mycophenolate mofetil) capsules, 250 mg, distributed nationwide in the US. The recall was initiated on 27 Sep 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-097-2013
- FDA event ID
- 63874
- Recalling firm
- Genentech, South San Francisco, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Sep 2012
- FDA classified
- 20 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 27 Sep 2012 | Recall initiated by company | |
| 20 Dec 2012 | Classified by FDA | +84 days |
| 26 Dec 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Short Fill: some bottles contained less than 120-count per labeled claim.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is CellCept (mycophenolate mofetil) capsules, 250 mg recalled?
Yes. Genentech recalled CellCept (mycophenolate mofetil) capsules, 250 mg on 27 Sep 2012. The recall is Class III and its status is Terminated. Recall number D-097-2013.
Why was it recalled?
Short Fill: some bottles contained less than 120-count per labeled claim.
Which lots are affected?
Lot #: a) M1365B01, Exp 04/15; b) M1365, Exp 04/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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