MHRA Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)
Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd)
Drug alert number: EL (24)A/33
MDR number: MDR 113-05/24
Date issued: 30 July 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)
Company name: Glenmark Pharmaceuticals Europe Ltd
Product name: Atomoxetine 10mg Hard Capsules, PL 25258/0270
SNOMED Code: 337277411000001106
| Batch Number | Expiry date | Pack size | First distributed |
| 1201584 | 31-Jan-2025 | 28 | 28-Apr-2022 |
| 1203056 | 31-Jan-2025 | 28 | 27-May-2022 |
| 1203859 | 31-Mar-2025 | 28 | 12-Jul-2022 |
| 1205342 | 31-May-2025 | 28 | 26-Jul-2022 |
| 1205816 | 31-May-2025 | 28 | 25-Aug-2022 |
| 1208831 | 31-May-2025 | 28 | 30-Nov-2022 |
| 1208832 | 31-Jul-2025 | 28 | 05-Dec-2022 |
| 1211181 | 31-Oct-2025 | 28 | 15-Feb-2023 |
| 1211187 | 31-Oct-2025 | 28 | 16-Mar-2023 |
| 1302767 | 28-Feb-2026 | 28 | 24-May-2023 |
| 1302768 | 31-Dec-2025 | 28 | 24-May-2023 |
| 1307838 | 31-Jul-2026 | 28 | 12-Oct-2023 |
| 1307883 | 31-Jul-2026 | 28 | 17-Oct-2023 |
| 1307884 | 31-Jul-2026 | 28 | 17-Oct-2023 |
| 1310439 | 31-Oct-2026 | 28 | 03-Jan-2024 |
| 1311234 | 31-Oct-2026 | 28 | 19-Jan-2024 |
Product name: Atomoxetine 18mg Hard Capsules, PL 25258/0271
SNOMED Code: 37535211000001107
| Batch Number | Expiry date | Pack size | First distributed |
| 1207734 | 30-Jun-2025 | 28 | 16-Nov-2022 |
| 1207741 | 31-Jul-2025 | 28 | 30-Nov-2022 |
| 1208833 | 31-Jul-2025 | 28 | 05-Dec-2022 |
| 1302771 | 28-Feb-2026 | 28 | 24-May-2023 |
| 1307741 | 30-Jun-2026 | 28 | 17-Oct-2023 |
| 1400621 | 30-Nov-2026 | 28 | 28-Feb-2024 |
| 1400622 | 30-Nov-2026 | 28 | 13-Mar-2024 |
Product name: Atomoxetine 25mg Capsules, PL 25258/0272
SNOMED Code: 37531811000001105
| Batch Number | Expiry date | Pack size | First distributed |
| 1201599 | 30-Oct-2024 | 28 | 30-Mar-2022 |
| 1203920 | 31-Mar-2025 | 28 | 08-Jul-2022 |
| 1208834 | 31-Aug-2025 | 28 | 25-Nov-2022 |
| 1211263 | 31-Aug-2025 | 28 | 15-Feb-2023 |
| 1302773 | 28-Feb-2026 | 28 | 24-May-2023 |
| 1308796 | 31-Aug-2026 | 28 | 17-Nov-2023 |
Product name: Atomoxetine 40mg Hard Capsules, PL 25258/0273
SNOMED Code: 37535411000001106
| Batch Number | Expiry date | Pack size | First distributed |
| 1201647 | 31-Dec-2024 | 28 | 09-May-2022 |
| 1205403 | 31-May-2025 | 28 | 26-Jul-2022 |
| 1211316 | 30-Sep-2025 | 28 | 16-Feb-2023 |
Product name: Atomoxetine 60mg Hard Capsules, PL 25258/0274
SNOMED Code: 37532411000001103
| Batch Number | Expiry date | Pack size | First distributed |
| 1208837 | 31-Aug-2025 | 28 | 05-Dec-2022 |
| 1211733 | 30-Nov-2025 | 28 | 15-Feb-2023 |
| 1308188 | 31-Jul-2026 | 28 | 30-Oct-2023 |
Product name: Atomoxetine 80mg Hard Capsules, PL 25258/0275
SNOMED Code: 37533211000001108
| Batch Number | Expiry date | Pack size | First distributed |
| 1205406 | 31-Mar-2025 | 28 | 26-Jul-2022 |
| 1309733 | 30-Sep-2026 | 28 | 30-Nov-2023 |
Product name: Atomoxetine 100mg Hard Capsules, PL 25258/0276
SNOMED Code: 37533711000001101
| Batch Number | Expiry date | Pack size | First distributed |
| 1211509 | 31-Oct-2025 | 28 | 28-Feb-2023 |
| 1309825 | 30-Sep-2026 | 28 | 18-Dec-2023 |
Active Pharmaceutical Ingredient: Atomoxetine Hydrochloride
Brief description of the problem
Glenmark Pharmaceuticals Europe 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 for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View full alert here.
Advice for 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.
Further Information
For medical information enquiries please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com
For stock control enquiries please email orders.uk@glenmarkpharma.com
