Recurring concern
Inadequate product safety warnings about serious hazards
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Request correctionFirst reported 16 Oct 2013•Latest report 4 Nov 2025
What this concern includes
Includes failures of product packaging, labels or enclosed product information to provide sufficiently visible, prominent, complete and intelligible warnings about serious hazards associated with using or misusing the product, including inhalation, poisoning, fire, choking and comparable risks.
Not included
- Excludes road, premises, workplace and public-location warning signs where the warning is not part of product packaging or product information.
- Excludes generic product defects or unsafe product design where the warning or labelling control is not itself deficient.
- Excludes dosage, instructions or general consumer information unless the reported deficiency concerns communicating a serious product-safety hazard through packaging or accompanying product information.
- Excludes warnings for a named clinical, transport or operational safety system where that system supplies the more specific supported parent boundary.
- Reports
- 20
- Individual concerns
- 26
- Date range
- 2013–2025
- Stated actions
- 48
Distinct published reports
A report can raise multiple concerns
First to latest report issue date
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
Most frequent recipients
Reports about this concern sent to each recipient.
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
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Concerns raised2
Failure of naked-flame danger warnings to be sufficiently large and prominent
Absence of naked-flame danger warnings on the body of the automatic air freshener
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.2
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Action
Apply high-contrast safety warnings, hazard pictograms and labelling to the refill canister and product packaging.
Stated by S. C. Johnson & Son, Inc. -
Action
Assess the product labelling against applicable regulatory requirements, guidelines and industry standards.
Stated by S. C. Johnson & Son, Inc.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
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Position
Existing packaging and refill labelling is considered sufficient; labelling the dispenser is not required and could mislead consumers.
Stated by S. C. Johnson & Son, Inc.
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Concerns raised1
Failure to display fire-risk warnings on all product packaging
This report raised 8 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.6
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Action
Develop consistent, clear warning wording for paraffin-containing emollient packaging and patient information.
Stated by PAGB -
Action
Submit proposed warning wording for user-testing to assess whether consumers understand it clearly.
Stated by PAGB -
Action
Work with the Medicines and Healthcare products Regulatory Agency to implement a consistent standard warning on packaging and patient information leaflets after user-testing.
Stated by PAGB
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Action
Undertake an in-depth review of emollient instructions for use and reported adverse incidents.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Work with manufacturers to raise awareness of emollient fire risks.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Ask manufacturers and notified bodies to review products and undertake relevant fire-risk assessments.
Stated by Medicines and Healthcare products Regulatory Agency
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
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Position
Warnings on emollient packaging and to the general public are matters for other recipients with a broader remit.
Stated by Locala Community Partnerships
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Concerns raised1
Failure of intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.4
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Action
Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.
Stated by Medicines and Healthcare products Regulatory Agency
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Action
Request the Buscopan Ampoules licence holder to revise product information to clarify cardiac risks and recommend monitoring and readily available emergency equipment and trained personnel.
Stated by Medicines and Healthcare products Regulatory Agency
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Concerns raised1
Lack of fire-hazard warnings on E45 prescriptions and product packaging
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.5
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Action
Add fire-risk label warnings to emollient products containing predominantly paraffin-based ingredients.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Take regulatory action to require similar fire-risk warnings on all emollient medicines, including aqueous-based products such as E45 Cream.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Conduct an additional safety assessment and reassess flammability labelling across the E45 product portfolio.
Stated by RB
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Action
Submit an MHRA variation application to add flammability warnings and safe-use guidance to specified E45 medicinal and cosmetic products.
Stated by RB -
Action
Release the specified E45 medicinal and cosmetic products with revised labels containing flammability warnings and safe-use guidance.
Stated by RB
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Concerns raised1
Failure to provide a prominent warning about the risk of fatal carbon monoxide poisoning from indoor use
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
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Concerns raised1
Failure to prominently communicate the danger of taking a hot bath whilst wearing the patch
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
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Action
Report the incident to the Medicines and Healthcare Products Regulatory Agency.
Stated by Takeda
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
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Position
The current Matrifen leaflet adequately addresses the risk of exposing patches to heat sources.
Stated by Takeda
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Concerns raised4
Failure to include required CLP hazard statements
Failure to use CLP-standard hazard pictograms
Failure to include the CLP signal word “danger”
Failure to provide a tactile warning on the container
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
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Action
Send the coroner’s report and recommendations to Darlington Trading Standards for investigation of the product’s labelling.
Stated by Department for Business, Innovation & Skills
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
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Position
Responsibility for CHIP/CLP labelling of poppers lies with the Health and Safety Executive, not this Department.
Stated by Department for Business, Innovation & Skills
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Position
Darlington Trading Standards is responsible for investigating compliance with CHIP/CLP labelling requirements and deciding enforcement action.
Stated by Department for Business, Innovation & Skills
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Concerns raised2
Failure to include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS
Failure to include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
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Concerns raised1
Absence of choking-risk warnings on packets of raw jelly
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
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Action
Forward the report to relevant food manufacturing and retail trade bodies for information and consideration regarding warnings about raw jelly cube risks.
Stated by Food Standards Agency
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
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Position
Warnings on food-product packaging are outside Ofsted’s remit.
Stated by Ofsted
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Position
The Food Standards Agency will respond about possible further action on warnings for raw jelly packaging.
Stated by Ofsted -
Position
There is no specific legal requirement to require warnings on packaging or loose-food point-of-sale notices; manufacturers and retailers may act voluntarily.
Stated by Food Standards Agency
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Concerns raised1
Danger of treating caffeine-containing energy mints as ordinary sweets
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
Data last updated 7 September 2026