Medicines recallMHRA
Oxbryta 500mg Tablets (voxelotor) recalled over a quality concern
Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.
Check your product
Only products that match these details are covered. Have your pack in front of you.
7 identifiers listed for this notice.
Oxbryta 500mg Tablets (voxelotor) 90
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 1941738
- 1997214
- Product licenceThe PL number on the carton.
- PLGB 00057/1720
- ExpiryOn the carton, blister or label.
- 31-Mar-2025
- 30-Nov-2025
- First distributedOn the product, its label or its packaging.
- 22-Jan-2023
- 15-Jul-2024
What to do now
Affected batches of Oxbryta 500mg Tablets (voxelotor) are subject to a recall or defect notice.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
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
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/44). Quoted as issued.
Summary
Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.
The risk
Product Information DMRC Number DMRC-32749585
Advice for healthcare professionals
Stop supplying the above product immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Physicians, specialist prescribers, homecare company providers or any other healthcare professional responsible for prescribing Oxbryta should contact all patients undergoing treatment and advise them to discontinue treatment and, where appropriate, discuss alternative treatment options. Patients should be instructed to return the product to the hospital pharmacy or homecare company that dispensed it.
Patients should continue to be monitored for adverse events after their treatment with Oxbryta is discontinued and ensure appropriate follow-up as needed. New patients should not start treatment with Oxbryta. More information can be found in the Direct Healthcare Professional Letter shared with this notification.
Pfizer Limited has informed the MHRA that all batches of Oxbryta 500 mg Tablets are being withdrawn due to emerging data from clinical trials and registry-based studies that now indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. The data suggest an unfavourable imbalance in vaso-occlusive crises (acute painful crises) and fatal events (deaths).
Your healthcare professional responsible for your care and treatment will contact you to advise you or the child under your care being treated to stop taking Oxbryta 500 mg Tablets, and where appropriate, discuss alternative treatment options. They will also advise how to return any remaining packs of Oxbryta 500mg Tablets that you have in your possession. If you have not already been contacted by your healthcare professional, please contact them.
If you experience adverse reactions, have a sudden worsening of clinical condition, or have any questions about your medication, you should seek medical attention. If you have any concerns about your health or the health of somebody else, consult with your healthcare professional. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
Pfizer Limited has informed the MHRA that all batches of Oxbryta 500 mg Tablets are being withdrawn due to emerging data from clinical trials and registry-based studies that now indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. The data suggest an unfavourable imbalance in vaso-occlusive crises (acute painful crises) and fatal events (deaths).
Your healthcare professional responsible for your care and treatment will contact you to advise you or the child under your care being treated to stop taking Oxbryta 500 mg Tablets, and where appropriate, discuss alternative treatment options. They will also advise how to return any remaining packs of Oxbryta 500mg Tablets that you have in your possession. If you have not already been contacted by your healthcare professional, please contact them.
If you experience adverse reactions, have a sudden worsening of clinical condition, or have any questions about your medication, you should seek medical attention. If you have any concerns about your health or the health of somebody else, consult with your healthcare professional. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Oxbryta 500mg Tablets (voxelotor) been recalled?
Affected batches of Oxbryta 500mg Tablets (voxelotor) are subject to a recall or defect notice. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
How do I know if my medicine is affected?
Compare the batch code, product licence, 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?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.