Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26
Read and act on the official notice on GOV.UK
The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 this recall | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
In plain English, for the pharmacy team
Why is this relevant to community pharmacy
ChloraPrep is a skin antiseptic used by healthcare professionals. The Medicines and Healthcare products Regulatory Agency (MHRA) says some batches may have a breach of sterility in the packaging process, which could raise the risk of contamination and infection. This may affect stock held in the pharmacy. This product is mainly used by healthcare professionals.
What to tell patients
Use your professional judgement for each patient.
- No further action is required by patients as this product is used by healthcare professionals only and they will have taken the action to remove this product from use.
- The recall is a precautionary measure to reduce any extra risk of infection.
- If you have any questions about your medication, or if you have had an adverse reaction, seek medical attention.
- Report suspected adverse reactions through the MHRA Yellow Card scheme.
What needs to be done
- Stop supplying the affected batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5mL applicators.
- Quarantine all remaining stock of the affected batches.
- Return the quarantined stock to your supplier using your supplier’s approved process.
- Pharmacists: note that batches with an expiry date after 02/2028 are not impacted.
- Be aware that the product is used by healthcare professionals only, and the notice says they will have taken action to remove it from use.
- Read and act on the official GOV.UK notice.
Pharmshark summary, checked and approved by Chris Dotchin on 2 Nov 2026. It is not the official notice: always read and act on the GOV.UK notice.
How this summary was written
An AI tool drafted it from the MHRA's own notice and nothing else. A second check compared every line with the notice. Pharmshark's clinical lead then read it against the notice, edited it where needed and approved it. If the MHRA changes the notice, this summary is taken down until it has been checked again.
The MHRA's summary
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
Not the full list. Further batches are listed in an annex to the notice — open the GOV.UK notice for every batch.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators | |||
| All lots with an expiry date up to and including 02/2028 * | All lots with an expiry date up to and including 02/2028 | ChloraPrep 1mL Applicator: 60 applicators | 11/09/2023 |
| All lots with an expiry date up to and including 01/2028 * | All lots with an expiry date up to and including 01/2028 | ChloraPrep Frepp™ 1.5 ml Applicators: 20 applicators | 09/01/2024 |
MHRA's audience tags: Dispensing GP practices, General practice, Pharmacy