The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0441-2017·Announced 2017-02-01

Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

Mylan LLC is recalling specific lots of Temozolomide Capsules, 100 mg, because customer complaints reported broken or crushed capsules resulting in 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 moderate severity.

Plain-English summary

Mylan LLC is recalling Temozolomide Capsules, 100 mg, packaged in 5-count and 14-count bottles. The recall affects specific lots distributed nationwide in the USA. The affected products are identified by NDC 0378-5262-98 (5-count) and NDC 0378-5262-14 (14-count).

The recall was initiated due to customer complaints of broken or crushed capsules, which resulted in loose powder in the bottle. This is classified as an FDA Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected lots immediately. The specific lots involved are 2006895 and 2006896, both with an expiration date of 02/18. Consumers should contact their healthcare provider or pharmacist for guidance on obtaining replacement medication.

The recalled product

Product
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.
Manufacturer
Mylan LLC.
Category
Drug — Oncology
Hazard

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 (3)

  • LOT #: a) 2006895 and 2006896
  • Exp 02/18
  • b) 2006895

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 →

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