Merck announced a voluntary recall of Temodar (temozolomide) and its generic Temozolomide (Sandoz) capsules due to the potential for the bottle caps to be cracked.

The capsules were distributed in 5- and 14-count brown glass bottles that have white plastic child-resistant caps. A white label affixed to the bottle has the word “Temozolomide” printed in black lettering. It was sold in clinics and pharmacies nationwide as a prescribed medicine from July 2013 to August 2015. Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of Temodar and Temozolomide capsules could potentially have cracked caps.

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All bottle caps of Temodar and Temozolomide capsules should be immediately inspected for cracks. If the cap has a crack, patients should immediately place the bottle out of the sight and reach of young children, as a crack in the bottle cap could render the closure no longer child-resistant. Patients wishing to obtain a replacement cap, ask questions, or who need assistance, should call the Merck Information Center. Because the quality of the medication in the bottles is not affected, patients may continue to use the drug as directed. Retailers, pharmacists, and health care professional should also inspect caps for cracks. Any bottle with a cracked cap should not be distributed to patients.

Temozolomide is an alkylating agent indicated for the treatment of newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma. Temodar in sachets are not affected.

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