CLASS II Drug recall · Reported 6 Feb 2013 · FDA Enforcement Report
Temodar (temozolomide) Capsule per package, For Oral Administration recalled
Schering-Plough Products is recalling Temodar (temozolomide) Capsule per package, For Oral Administration, distributed nationwide in the US. The recall was initiated on 12 Dec 2012 and the FDA has classified it as Class II.
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-139-2013
- FDA event ID
- 63879
- Recalling firm
- Schering-Plough Products, Las Piedras, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2012
- FDA classified
- 30 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 Dec 2012 | Recall initiated by company | |
| 30 Jan 2013 | Classified by FDA | +49 days |
| 6 Feb 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Temodar (temozolomide) Capsule per package, For Oral Administration recalled?
Yes. Schering-Plough Products recalled Temodar (temozolomide) Capsule per package, For Oral Administration on 12 Dec 2012. The recall is Class II and its status is Terminated. Recall number D-139-2013.
Why was it recalled?
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Which lots are affected?
Lot: 0NCW005, Exp 02/2013
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.