Class 3 Medicines Recall: Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules, EL(24)A/19
Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.
MDR Number: MDR 078-05/24
Company name: Neuraxpharm UK Ltd
Product description: Atomoxetine 10mg Capsules, PL 49718/0010
SNOMED Code: 37858111000001106
Details of the affected batch:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1211145 | 09/2025 | 7 | 23/02/2023 |
| 1203816 | 03/2025 | 7 | 07/07/2022 |
Product description: Atomoxetine 18mg Capsules, PL 49718/0011
SNOMED Code: 37858311000001108
Details of the affected batch:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1211146 | 09/2025 | 7 | 23/02/2023 |
Product description: Atomoxetine 25mg Capsules, PL 49718/0012
SNOMED Code: 37858511000001102
Details of the affected batch:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1211147 | 06/2025 | 7 | 23/02/2023 |
| 1207940 | 06/2025 | 7 | 24/10/2022 |
Product description: Atomoxetine 40mg Capsules, PL 49718/0013
SNOMED Code: 37900111000001107
Details of the affected batch:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1211148 | 09/2025 | 7 | 23/02/2023 |
| 1203818 | 03/2025 | 7 | 07/07/2022 |
Active Pharmaceutical Ingredient: Atomoxetine
Brief description of problem:
Neuraxpharm UK Ltd is recalling the above batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.
Advice to Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme
Company contacts for further information:
For medical information enquiries please contact medinfo-uk@neuraxpharm.com or telephone +44 (0) 118 211 4039
For stock control enquiries please contact info-uk@neuraxpharm.com or telephone +44 (0) 118 211 4039
To access the full recall: