Medicines defect noticeMHRA
Benzylpenicillin benzathine 1.2 Million I.U defect notice over a labelling error
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
Check your product
Only products that match these details are covered. Have your pack in front of you.
4 identifiers listed for this notice.
Benzylpenicillin benzathine 1.2 Million I.U 1
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 72500107
- 72500105
- ExpiryOn the carton, blister or label.
- 31/10/2029
- First distributedOn the product, its label or its packaging.
- 26/06/2026
What to do now
A printing or labelling mistake affects some packs of Benzylpenicillin benzathine 1.2 Million I.U.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/30). Quoted as issued.
Summary
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
The risk
DMRC reference number DMRC- 39917416 Marketing Authorisation Holder
Advice for healthcare professionals
Healthcare professionals should read the details in this notification and take this into account when reconstituting and administering these products.
Upon request, Brancaster Pharma Limited will provide hard copies of the updated PIL to wholesalers and pharmacies so that any packs can be supplemented with the correct PIL information.
To request hard copies of the PIL, please contact enquiries@brancasterpharma.com with your details, i.e. address, product with batch details, required number of leaflets.
The correct PIL is available:
Click here
The information in the updated PIL reflects the current section 6.6 of the SmPC:
Click here
The quality of the powder for suspension for injection is not affected by this issue.
The information missing from the Patient Information Leaflet (PIL) relates only to updated instructions for healthcare professionals on the preparation and administration of the injection.
These products are prepared and administered by healthcare professionals and the missing information has been provided to them when preparing the medication. No further action is required for the patient.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
The quality of the powder for suspension for injection is not affected by this issue.
The information missing from the Patient Information Leaflet (PIL) relates only to updated instructions for healthcare professionals on the preparation and administration of the injection.
These products are prepared and administered by healthcare professionals and the missing information has been provided to them when preparing the medication. No further action is required for the patient.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Benzylpenicillin benzathine 1.2 Million I.U been recalled?
A printing or labelling mistake affects some packs of Benzylpenicillin benzathine 1.2 Million I.U. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.