Genentech Recalls CellCept Capsules Due to Short Fill
Genentech recalls specific lots of CellCept (mycophenolate mofetil) capsules because some bottles contain fewer than the labeled 120-count.
Use caution until it’s fixed
Short Fill: some bottles contained less than 120-count per labeled claim.
Contact the company
What happened, in plain English
Genentech, Inc. is recalling specific lots of CellCept (mycophenolate mofetil) capsules, 250 mg, due to a short fill issue. Some bottles contained less than the 120-count stated on the label. The recall affects 1,128 bottles distributed nationwide. Read more at govinfonow.com/recall/48530-genentech-inc-recalls-cellcept-mycophenolate-mofetil-capsules-250-mg-packaged.
Source Summary by GovInfoNow · govinfonow.com/recall/48530-genentech-inc-recalls-cellcept-mycophenolate-mofetil-capsules-250-mg-packaged · Updated October 13, 2026 · FDA enforcement record: FDA #D-097-2013
Cite this page
“Genentech Recalls CellCept Capsules Due to Short Fill.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48530-genentech-inc-recalls-cellcept-mycophenolate-mofetil-capsules-250-mg-packaged. Based on FDA recall #D-097-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-097-2013%22&limit=1).
Why it’s dangerous
The hazard is a manufacturing error where some bottles contain fewer capsules than labeled. This discrepancy means patients may not receive the full quantity of medication they paid for or were prescribed, potentially impacting their treatment plan if not addressed.
Who’s affected
Patients prescribed CellCept capsules who purchased the affected lots from pharmacies or distributors nationwide are likely to be affected. Individuals relying on the full 120-count for their treatment regimen are at risk of receiving less medication than expected.
How to tell if you have this one
Check your CellCept bottle for NDC 0004-0259-05 (12 x 120-count bottles per carton) or NDC 0004-0259-51 (120-count capsules per bottle). Verify the lot number is M1365B01 or M1365 and the expiration date is 04/15. The product was made in Ireland and distributed by Genentech USA, Inc.
- Brand
Genentech- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your CellCept bottle matches the NDC, lot numbers (M1365B01 or M1365), and expiration date (04/15) listed in the recall.
Contact Your Pharmacist
If you have the affected product, contact your pharmacist or healthcare provider to discuss how to replace the medication or obtain a refund.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-097-2013 (September 27, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-097-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.