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Priority review Notice Amended Final

Apixaban Tablets Defect Notification - MHRA

MHRA Guidance & Safety

Published March 26th, 2026

Detected March 26th, 2026

Summary

The MHRA has issued a defect notification for Sandoz Limited's Apixaban 2.5mg and 5mg tablets. Certain batches have been distributed with Patient Information Leaflets that lack up-to-date information regarding paediatric indications and post-catheter removal guidance. Affected batches will continue to be distributed without repackaging.

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What changed

The MHRA has issued a Class 4 Medicines Defect Notification concerning Sandoz Limited's Apixaban 2.5mg and 5mg tablets. The issue pertains to the Patient Information Leaflet (PIL) included in 28 affected batches, which omits crucial updated information on paediatric indications (children aged 28 days to <18 years) and revised guidance for use following spinal/epidural catheter removal. Despite the defect, the MHRA, in consultation with the Department of Health and Social Care, has determined these products are critical for patients and will not be repackaged. Batches not yet distributed will also be released with the incorrect PIL.

Healthcare providers and pharmacies should be aware of this notification. While no specific action is mandated for the affected batches due to their critical nature, awareness of the missing information is paramount for patient counseling. Future manufactured batches will include the updated PIL. The DMRC reference number for this notification is DMRC-38614094.

What to do next

Note the defect notification for Sandoz Apixaban 2.5mg and 5mg tablets.
Be aware of the missing information in the Patient Information Leaflet for affected batches.
Ensure patients are informed about the updated guidance if dispensing affected batches.

Source document (simplified)

Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17

Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information.

From: Medicines and Healthcare products Regulatory Agency Published 26 March 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices and Pharmacy Issued: 26 March 2026

DMRC reference number

DMRC-38614094

Marketing Authorisation Holder

Sandoz Limited

Medicine Details

Apixaban 5mg Tablets

PL: 04416/1608

Active Ingredient: apixaban

SNOMED code: 40640311000001107

GTIN (28 tablets): 07613421102531

GTIN (56 tablets): 07613421102548

Affected Lot Batch Numbers

| Batch No. | Expiry Date | Pack Size | First Distributed |
| --- | --- | --- | --- |
| PS2891 | 30/06/2028 | 56 | 19/01/2026 |
| PT0565 | 30/06/2028 | 56 | 16/01/2026 |
| PT1417 | 31/07/2028 | 56 | 19/01/2026 |
| PU0476 | 31/07/2028 | 56 | 15/01/2026 |
| PU0481 | 31/08/2028 | 56 | 15/01/2026 |
| PV5375 | 31/07/2028 | 28 | Not yet distributed |
| PW1623 | 31/07/2028 | 28 | Not yet distributed |
| PW1624 | 30/04/2028 | 28 | Not yet distributed |

Medicine Details

Apixaban 2.5mg Tablets

PL: 04416/1607

Active Ingredient: apixaban

SNOMED code: 40655511000001108

GTIN (10 tablets) 07613421102500

GTIN (20 tablets): 07613421102517

GTIN (60 tablets): 07613421102524

Affected Lot Batch Numbers

| Batch No. | Expiry Date | Pack Size | First Distributed |
| --- | --- | --- | --- |
| PU1963 | 31/07/2028 | 60 | 15/01/2026 |
| PU3287 | 31/01/2028 | 20 | 15/01/2026 |
| PT4596 | 31/07/2028 | 60 | 15/01/2026 |
| PT2868 | 31/07/2028 | 60 | Not yet distributed |
| PU2604 | 31/07/2028 | 60 | Not yet distributed |
| PU2605 | 31/07/2028 | 60 | Not yet distributed |
| PU2606 | 31/07/2028 | 60 | Not yet distributed |
| PT1722 | 30/11/2027 | 10 | Not yet distributed |

Background

Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet (PIL) included in the affected batches of Apixaban does not contain up‑to‑date information relating to:

The newly authorised paediatric indication (children aged 28 days to <18 years), and
Updated guidance regarding use following spinal/epidural catheter removal. The updated PIL wording is shown in Table 1 and will be included in all future manufactured batches.

The batches listed as ‘not yet distributed’ have also been manufactured and packed with the previous PIL version. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in this notification.

All subsequently manufactured batches will include the updated PIL.

Table 1- Summary of the updated safety information missing from the packed PIL:

| PIL Section | New PIL Wording (Actual Text) |
| --- | --- |
| Section 1 - What is Apixaban used for | “Apixaban is used in children aged 28 days to less than 18 years to treat blood clots and to prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs. For body weight appropriate recommended dose, see section 3.” |
| Section 2 - What you need to know before you take Apixaban (Warnings and precautions) | “Talk to your doctor, pharmacist or nurse before you take this medicine if you have any of the following: Had a tube (catheter) or an injection into your spinal column (for anaesthesia or pain reduction), your doctor will tell you to take this medicine 5 hours or more after catheter removal.” |
| Section 3 - How to Take Apixaban (Paediatric Dosing) | “Use in children and adolescents… The dose depends on the body weight, and will be calculated by the doctor. Paediatric posology: Two tablets of Apixaban 5 mg twice a day for 7 days, then one tablet twice daily thereafter. Caregivers should observe dosing; scheduled doctor visits may be required to adjust weight-based dose.” |

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

Advice for Healthcare Professionals to Provide to 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.

Additional information:

For all medical information enquiries and information on this product, please email mi.uk@sandoz.com, or telephone +44 1276 698101.

For stock control enquiries please email sales.sandoz-gb@sandoz.com, or telephone +44 1276 698020.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk