Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
Mylan LLC is recalling 588 bottles of Temozolomide Capsules, 250 mg, due to customer complaints of broken capsules and loose powder in the bottles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves physical integrity issues (broken capsules) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Mylan LLC is recalling 588 bottles of Temozolomide Capsules, 250 mg, 5-count bottles (NDC 0378-5265-98). The recall is due to customer complaints of broken or crushed capsules, which resulted in loose powder in the bottle.
The affected product is identified by Lot # 2006912 with an expiration date of 02/18. The product was distributed nationwide in the USA.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
- Manufacturer
- Mylan LLC.
- Category
- Drug — Oncology
- Affected units
- 588
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- LOT #: 2006912
- Exp 02/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Mylan LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Mylan LLC.
See all →- ModerateMylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
FDA (Drugs) · 2017-02-01
- ModerateMylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
FDA (Drugs) · 2017-02-01
- ModerateMylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
FDA (Drugs) · 2017-02-01
- ModerateMylan Recalls Tacrolimus Capsules for Failed USP Content Uniformity Requirements
FDA (Drugs) · 2012-12-05
Same hazard · physical integrity
See all →- ModeratePfizer Recalls Thermacare HeatWraps Menstrual Due to Material Leakage
FDA (Devices) · 2018-12-12
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