CLASS II Drug recall · Reported 1 Feb 2017 · FDA Enforcement Report
Temozolomide Capsules, 100 mg recalled by Mylan
Mylan is recalling Temozolomide Capsules, 100 mg, distributed nationwide in the US. The recall was initiated on 20 Dec 2016 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-0441-2017
- FDA event ID
- 76020
- Recalling firm
- Mylan, Caguas, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2016
- FDA classified
- 25 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
Timeline
| 20 Dec 2016 | Recall initiated by company | |
| 25 Jan 2017 | Classified by FDA | +36 days |
| 1 Feb 2017 | 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 Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
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
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Which lots are affected?
LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
Where was it sold?
Nationwide in the USA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 76020| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Temozolomide Capsules, 250 mg recalled by Mylan | Mylan | Other | Nationwide | |
| CLASS II | Temozolomide Capsules, 180 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide | |
| CLASS II | Temozolomide Capsules, 140 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide |
More recalls from Mylan
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 180 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Mylan | Mylan | Other | Nationwide |
| Drug | CLASS II | Tacrolimus Capsules 0.5 mg recalled by MylanTacrolimus | Mylan | Potency & Assay | PR |
Other Temozolomide recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Product label: Temozolomide Capsules, 5mg recalledTemozolomide | Rising Pharma Holding | Potency & Assay | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 20 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |