Severity
Moderate
ModerateActive
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 …
Merck Sharp & Dohme Corp., of Whitehouse Station, N.j. recalled This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsul… - a moderate-severity action.
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 moderate-severity CPSC recall-The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young chil….
- Moderate
- severity level
- 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 CPSC action (record #15219) was formally reported on August 18, 2015. It is classified under Moderate severity, with a current status of Active. Merck Sharp & Dohme Corp., of Whitehouse Station, N.j. is listed as the recalling firm. Federal records list the affected scope as About 276,000.
The documented reason for this recall is: 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. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: 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 u… - consumers holding this product should act on that instruction 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
About 276,000
Related Recalls
6
0 from same agency
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
| Attribute | Value |
|---|---|
| Agency | U.S. Consumer Product Safety Commission |
| Severity class | Moderate |
| 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. Severity: Moderate. Recall number: 15219.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (15219) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: CPSC, reported August 18, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.