Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17
Summary
The MHRA has issued a Class 4 defect notification for specified batches of Sandoz Apixaban 2.5mg and 5mg tablets (PL 04416/1607 and PL 04416/1608) distributed since January 2026. The Patient Information Leaflet (PIL) included in affected batches is missing updated safety information on the newly authorised paediatric indication for children aged 28 days to under 18 years, and updated guidance on administration at least 5 hours after spinal or epidural catheter removal. The tablets themselves are unaffected; the defect involves labelling only. Healthcare professionals are advised to inform patients and carers of the updated dosing information for children and to contact Sandoz Limited or access the Electronic Medicines Compendium for corrected PILs.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
Sandoz Limited has notified the MHRA that the Patient Information Leaflet (PIL) included in specified batches of Apixaban 2.5mg and 5mg tablets does not contain up-to-date information. Affected batches include PS2891, PT0565, PT1417, PU0476, and PU0481 (5mg), and PU1963, PU3287, PT4596, PT2868, PU2604, PU2605, PU2606, and PT1722 (2.5mg), with expiry dates between November 2027 and August 2028. The missing information relates to: the newly authorised paediatric indication for children aged 28 days to less than 18 years, and updated guidance requiring at least 5 hours delay after spinal or epidural catheter removal. The tablets themselves are not affected in quality.
Healthcare professionals managing anticoagulation therapy should be aware of the new paediatric dosing information and updated spinal/epidural catheter guidance. Where affected stock remains in circulation, pharmacists and dispensing GPs should request corrected PILs from Sandoz Limited (sales.sandoz-gb@sandoz.com) or direct patients to the Electronic Medicines Compendium. Patients should continue taking their medication as prescribed and be informed of the updated dosing advice for children and the revised catheter-removal timing.
Archived snapshot
Mar 26, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
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Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17
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