The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0442-2017·Announced 2017-02-01

Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

Mylan LLC is recalling Temozolomide Capsules, 140 mg, due to customer complaints of 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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The specific defect is physical (broken capsules/loose powder) rather than a high-risk pathogen or structural failure, fitting the Moderate criteria for minor defects or low-risk contamination.

Plain-English summary

Mylan LLC is recalling Temozolomide Capsules, 140 mg, packaged in 5-count and 14-count bottles. The recall is being conducted due to customer complaints of broken or crushed capsules, which resulted in loose powder in the bottle.

The affected products are identified by lot numbers 2006903 (5-count bottles) and 2006902 (14-count bottles), both with an expiration date of 02/18. The recall covers 746 bottles of lot 2006903 and 588 bottles of lot 2006902. These products were distributed nationwide in the USA.

Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
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.
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) 2006903
  • Exp 02/18
  • b) 2006902

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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