Mylan Temozolomide Capsules: Broken Capsules Cause Loose Powder
Mylan recalls 100mg Temozolomide capsules that may break or crush, causing loose powder. Patients should contact Mylan for details.
Lower-risk recall
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Contact the company
What happened, in plain English
Mylan is recalling 100mg Temozolomide capsules that may break or crush, leading to loose powder in the bottle. This could affect patients taking the medication as it may cause inconsistent dosing. Read more at govinfonow.com/recall/42112-mylan-temozolomide-capsules-broken-capsules-cause-loose-powder.
Source Summary by GovInfoNow · govinfonow.com/recall/42112-mylan-temozolomide-capsules-broken-capsules-cause-loose-powder · Updated October 8, 2026 · FDA enforcement record: FDA #D-0441-2017
Cite this page
“Mylan Temozolomide Capsules: Broken Capsules Cause Loose Powder.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42112-mylan-temozolomide-capsules-broken-capsules-cause-loose-powder. Based on FDA recall #D-0441-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0441-2017%22&limit=1).
Why it’s dangerous
The capsules may break or crush, causing loose powder to escape the bottle. This could lead to inconsistent medication dosing if the powder is not properly measured.
Who’s affected
Patients prescribed Temozolomide capsules by a healthcare provider. Those using the capsules as directed are most at risk if the capsules break or crush during handling.
How to tell if you have this one
Check for 100mg Temozolomide capsules in 5-count or 14-count bottles with NDC numbers 0378-5262-98 or 0378-5262-14. The lot numbers are 2006895 or 2006896, expiring February 2018.
- Brand
Mylan- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0441-2017 | 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.; LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18 | a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895) |
| D-0442-2017 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.; LOT #: a) 2006903, Exp 02/18; b) 2006902, Exp 02/18 | a) 746 bottles (lot 2006903); b)588 bottles (lot 2006902) |
| D-0443-2017 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.; LOT #: a) 2006915, Exp 02/18; b) 2006914, Exp 02/18 | a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914) |
| D-0444-2017 | Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.; LOT #: 2006912, Exp 02/18 | 588 bottles |
What to do — step by step
Check Capsule Integrity
Inspect the capsules for signs of breaking or crushing before use.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
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-0441-2017 (December 20, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0441-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.