Medicines defect noticeMHRA
Apixaban 2.5mg and 5mg Tablets defect notice over a labelling error
Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.
Check your product
Only products that match these details are covered. Have your pack in front of you.
32 identifiers listed for this notice.
Product 1 56
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- PS2891
- PT0565
- PT1417
- PU0476
- PU0481
- ExpiryOn the carton, blister or label.
- 30/06/2028
- 31/07/2028
- 31/08/2028
- First distributedOn the product, its label or its packaging.
- 19/01/2026
- 16/01/2026
- 15/01/2026
Product 2 28
- Batch code
- PV5375
- PW1623
- PW1624
- Expiry
- 31/07/2028
- 30/04/2028
- First distributed
- Not yet distributed
Product 3 60
- Batch code
- PU1963
- PT4596
- PT2868
- PU2604
- PU2605
- PU2606
- Expiry
- 31/07/2028
- First distributed
- 15/01/2026
- Not yet distributed
Product 4 20
- Batch code
- PU3287
- Expiry
- 31/01/2028
- First distributed
- 15/01/2026
Product 5 10
- Batch code
- PT1722
- Expiry
- 30/11/2027
- First distributed
- Not yet distributed
What to do now
A printing or labelling mistake affects some packs of Apixaban 2.5mg and 5mg Tablets.
- 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/17). Quoted as issued.
Summary
Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.
The risk
DMRC reference number DMRC-38614094 Marketing Authorisation Holder
Advice for healthcare professionals
Be aware of the updated information regarding the use of Apixaban in children aged 28 days to less than 18 years, and administration at least 5 hours after spinal/epidural catheter removal. Inform patients and carers of the approved dosing advice for children or patients with a catheter fitted.
Upon request, Sandoz Limited will provide hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact sales.sandoz-gb@sandoz.com with your details, i.e. address, product with batch details, required number of leaflets.
The updated PILs for each strength are available via the Electronic Medicines Compendium (eMC).
Apixaban Sandoz 2.5 mg film-coated tablets - Patient Information Leaflet (PIL) 13807
Apixaban Sandoz 5 mg film-coated tablets - Patient Information Leaflet (PIL) 13806
Patients should continue to take Apixaban as prescribed by their healthcare professional. The quality of the tablets is not impacted by the missing information. If patients have questions about these updates, they should speak to their pharmacist, nurse, or doctor.
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
Patients should continue to take Apixaban as prescribed by their healthcare professional. The quality of the tablets is not impacted by the missing information. If patients have questions about these updates, they should speak to their pharmacist, nurse, or doctor.
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 Apixaban 2.5mg and 5mg Tablets been recalled?
A printing or labelling mistake affects some packs of Apixaban 2.5mg and 5mg Tablets. 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.