Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement
U.S. Consumer Product Safety Commission recall (2015-08-18). Hazards: chemical. About 276,000 units in the US.
| Agency | U.S. Consumer Product Safety Commission |
|---|---|
| Recall number | 15219 |
| Published | 2015-08-18 |
| Last updated | 2015-08-19 |
| Product category | Tablet or Capsule Drugs |
| Products | Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules |
| Firm named in the title | Merck |
| Firms | Merck Sharp & Dohme Corp., of Whitehouse Station, N.J. (manufacturer) |
| Manufactured in | United States |
| Units (US) | 276,000 |
| Hazard classes | chemical |
| Remedy classes | replace, inspect |
| Sold | 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. |
Description
This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsules, an oral chemotherapy drug. 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.
Hazard
The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young children who can gain unintended access to the capsules, posing a risk of poisoning.
Remedy
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.
Incidents and injuries
None reported.
Machine access
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Source: U.S. Consumer Product Safety Commission recall notice (US Government work). Not affiliated with or endorsed by CPSC. Structured by Data Foundry (product-recall-structuring@2); last changed 2026-09-28. Always confirm with the agency notice.