Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Medium RiskCPSC
Medications & Supplements/Prescription Drugs

Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement

Agency Publication Date: August 18, 2015
Share:
Sign in to monitor this recall

Summary

Merck is recalling about 276,000 bottles of Temodar (temozolomide) and generic temozolomide capsules because the bottle caps can crack. These oral chemotherapy drugs were distributed in 5- and 14-count brown glass bottles with white plastic caps between July 2013 and August 2015. Consumers should inspect their bottle caps immediately and contact the manufacturer for a replacement if a crack is found, though they may continue taking the medication as directed by their doctor.

Risk

A cracked cap can cause the child-resistant closure to fail, allowing young children to open the bottle and access the capsules. This poses a serious risk of accidental poisoning from these chemotherapy medications.

What You Should Do

  1. Immediately check the white plastic caps on your brown glass bottles of Temodar (temozolomide) or generic temozolomide for any visible cracks.
  2. If you find a cracked cap, contact the Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday to request a replacement cap.
  3. Ensure all medication bottles are stored up high, out of sight, and completely out of the reach of young children at all times.
  4. You may continue to use the medication as directed by your healthcare provider while waiting for a replacement cap.
  5. For more information, visit www.merck.com and click on the 'Important Temodar Information' link.
  6. Call the CPSC Hotline at 800-638-2772 if you have additional safety questions regarding this recall.

Your Remedy Options

📋Replace

Consumers should immediately inspect their bottle caps for cracks. If a crack is found, consumers should contact Merck for a replacement cap. As with all drug products, the bottles should be stored up high, out of sight and reach of young children. Consumers may continue to use the drug as directed.

Contact: Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit www.merck.com and click on "Important Temodar Information" for more information.

Affected Products

Product: Temodar® (temozolomide) Capsules (5-count)
Model:
NDC 0085-1425-01
Date Ranges: Sold between July 2013 and August 2015
Product: Temodar® (temozolomide) Capsules (14-count)
Date Ranges: Sold between July 2013 and August 2015
Product: Temozolomide (generic) Capsules (5-count)
Model:
NDC 0781-2696-75
Date Ranges: Sold between July 2013 and August 2015
Product: Temozolomide (generic) Capsules (14-count)
Date Ranges: Sold between July 2013 and August 2015

Product Images

Temodar® (Temozolomide)

Temodar® (Temozolomide)

Close up view of the Temozolomide Capsules cracked cap rendering the child-resistant closure ineffective

Close up view of the Temozolomide Capsules cracked cap rendering the child-resistant closure ineffective

Additional Information

Agency: Consumer Product Safety Commission (CPSC)
Recall ID: 15219
Status: Active
Manufacturer: Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
Sold By: Clinics and pharmacies nationwide as a prescribed medicine from July 2013 to August 2015. The container was included in the cost of the medication which is based on quantities prescribed, health insurance terms and other factors.
Manufactured In: United States
Units Affected: About 276,000
Distributed To: Nationwide
Contact: Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit www.merck.com and click on "Important Temodar Information" for more information.
Agency Last Updated: August 19, 2015

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response