The Recall Desk
ModerateFDA (Drugs)·D-0443-2017·Announced 2017-02-01

Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

Mylan LLC is recalling Temozolomide Capsules, 180 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.

What this means for you

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 (broken capsules/loose powder) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Mylan LLC is recalling Temozolomide Capsules, 180 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 Temozolomide Capsules, 180 mg, Rx only, manufactured by Mylan Pharmaceuticals, Inc. The specific lots involved are 2006915 (5-count bottles, NDC 0378-5264-98) and 2006914 (14-count bottles, NDC 0378-5264-14). Both lots have an expiration date of 02/18. The products were distributed nationwide in the USA.

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
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.
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) 2006915
  • Exp 02/18
  • b) 2006914

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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Same hazard · physical integrity

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