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CPSC recall · Reported August 18, 2015

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

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 …

Recall #
15219
Affected scope
About 276,000
Verify with CPSC →
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Merck Sharp & Dohme Corp., of Whitehouse Station, N.j. recalled This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsul….

Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet C… was recalled by Merck Sharp & Dohme Corp., of Whitehouse Station, N.j. in August 18, 2015. Reason: The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young chil…. Remedy: Consumers should immediately inspect their bottle caps for cracks. If a crack is found, c…. Verify recall #15219 with the CPSC before acting.

The recall

Merck Sharp & Dohme Corp., of Whitehouse Station, N.j. issued this CPSC recall-The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young chil….

None
agency class
August 18, 2015
reported

Sourced from official CPSC enforcement records. Verify recall #15219 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. Consumers holding this product should act on the agency's documented remedy above rather than relying on general guidance.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448

Product 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.

Reason for recall

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, what to do

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.

Recall Profile

Structured summary of the CPSC recall record
Attribute Value
Agency U.S. Consumer Product Safety Commission
Severity class Not classified by agency
Status Active
Recall number 15219
Date reported August 18, 2015
Date initiated August 18, 2015
Recalling firm Merck Sharp & Dohme Corp., of Whitehouse Station, N.j.
Affected scope About 276,000
Distribution Not disclosed
Official source CPSC notice →

Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.

What to do with this recall

Consumers should immediately inspect their bottle caps for cracks. If a crack is found, consumers should contact Merck for a repl…

  • Check the recall number (15219) and product description against the item you own. Search the archive
  • Confirm the current status and remedy on the official CPSC notice before acting. CPSC notice
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official CPSC record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Merck Sharp & Dohme Corp., of Whitehouse Station, N.j.. Units affected: About 276,000.
Why was this product recalled?
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.
What should consumers do?
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.
Which agency issued this recall?
This recall was issued by the CPSC on August 18, 2015. CPSC does not publish a hazard classification for this recall. Recall number: 15219.
How do I report an injury from a recalled product?
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.

Nationwide recalls with similar severity or category timing

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: CPSC, reported August 18, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026