MHRA Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd)
Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd)
Drug alert number: EL (24)A/25
Date issued: 02 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 (Accord Healthcare Ltd)
Company name: Accord Healthcare Ltd
Product name: Atomoxetine 10mg Hard Capsules, PL 20075/1173
SNOMED Code: 337277411000001106
Batch Number | Expiry date | Pack size | First distributed |
1110078 | Jul 2024 | 28 | 08 Nov 2021 |
1111874 | Aug 2024 | 28 | 15 Dec 2021 |
1200540 | Oct 2024 | 28 | 15 Mar 2022 |
1203856 | Mar 2025 | 28 | 21 Jun 2022 |
1207106 | Jun 2025 | 28 | 24 Oct 2022 |
1300367 | Sep 2024 | 28 | 01 Mar 2023 |
1300368 | Oct 2025 | 28 | 02 May 2023 |
1308974 | Jul 2026 | 28 | 19 Jan 2024 |
1308975 | Aug 2026 | 28 | 19 Feb 2024 |
1111687 | Aug 2024 | 7 | 30 Dec 2021 |
1203285 | Mar 2025 | 7 | 20 Jun 2022 |
1207790 | Jun 2025 | 7 | 07 Nov 2022 |
1210683 | Sep 2025 | 7 | 16 Jan 2023 |
1304125 | Apr 2026 | 7 | 13 Jul 2023 |
1307898 | Jul 2026 | 7 | 08 Nov 2023 |
Product name: Atomoxetine 18mg Hard Capsules, PL 20075/1174
SNOMED Code: 37276511000001108
Batch Number | Expiry date | Pack size | First distributed |
1203283 | Mar 2025 | 28 | 16 Jun 2022 |
1203896 | Mar 2025 | 28 | 08 Sep 2022 |
1207494 | Jun 2025 | 28 | 31 Oct 2022 |
1208784 | Jun 2025 | 28 | 17 Jan 2023 |
1208785 | Jul 2025 | 28 | 28 Mar 2023 |
1307499 | Jun 2026 | 28 | 15 Dec 2023 |
1309668 | Sep 2026 | 28 | 07 Mar 2024 |
1111061 | Jul 2024 | 7 | 20 Dec 2021 |
1200640 | Aug 2024 | 7 | 21 Jun 2022 |
1300503 | Oct 2025 | 7 | 02 Mar 2023 |
1307890 | Jul 2026 | 7 | 08 Mar 2024 |
Product name: Atomoxetine 25mg Capsules, PL 49718/0012
SNOMED Code: 37276811000001106
Batch Number | Expiry date | Pack size | First distributed |
1110084 | Aug 2024 | 28 | 19 Nov 2021 |
1111119 | Aug 2024 | 28 | 11 Jan 2022 |
1200055 | Oct 2024 | 28 | 11 Feb 2022 |
1208724 | Jun 2025 | 28 | 23 Jan 2023 |
1309624 | Aug 2026 | 28 | 29 Jan 2024 |
1309625 | Sep 2026 | 28 | 28 Mar 2024 |
1309685 | Sep 2026 | 28 | 08 Mar 2024 |
1111692 | Aug 2024 | 7 | 14 Dec 2021 |
1200641 | Oct 2024 | 7 | 04 Apr 2022 |
1207151 | May 2025 | 7 | 23 Dec 2022 |
1306982 | Jun 2026 | 7 | 05 Apr 2024 |
1307214 | Jun 2026 | 7 | 29 Jan 2024 |
Product name: Atomoxetine 40mg Hard Capsules, PL 20075/1176
SNOMED Code:37277111000001101
Batch Number | Expiry date | Pack size | First distributed |
1110101 | Aug 2024 | 28 | 17 Nov 2021 |
1111708 | Oct 2024 | 28 | 25 Jan 2022 |
1203171 | Mar 2025 | 28 | 15 Jun 2022 |
1204488 | Mar 2025 | 28 | 25 Jul 2022 |
1205675 | Apr 2025 | 28 | 01 Sep 2022 |
1207018 | Jun 2025 | 28 | 20 Sep 2022 |
1307133 | Jun 2026 | 28 | 13 Sep 2023 |
1309726 | Sep 2026 | 28 | 08 Feb 2024 |
1200643 | Dec 2024 | 7 | 30 May 2022 |
1207152 | Jun 2025 | 7 | 03 Oct 2022 |
1300507 | Nov 2025 | 7 | 06 Mar 2023 |
1307251 | Jun 2026 | 7 | 22 Mar 2024 |
Product name: Atomoxetine 60mg Hard Capsules, PL 20075/1177
SNOMED Code:37276311000001102
Batch Number | Expiry date | Pack size | First distributed |
1111748 | Aug 2024 | 28 | 10 Dec 2021 |
1200173 | Aug 2024 | 28 | 07 Mar 2022 |
1200600 | Oct 2024 | 28 | 17 Oct 2022 |
1200601 | Oct 2024 | 28 | 19 Apr 2022 |
1206867 | Jun 2025 | 28 | 16 Jan 2023 |
1300717 | Dec 2025 | 28 | 31 Mar 2023 |
1308067 | Jul 2026 | 28 | 23 Oct 2023 |
1401176 | Nov 2026 | 28 | 13 Mar 2024 |
Product name: Atomoxetine 80mg Hard Capsules, PL 20075/1178
SNOMED Code: 37275711000001106
Batch Number | Expiry date | Pack size | First distributed |
1111226 | Aug 2024 | 28 | 13 Dec 2021 |
1203290 | Feb 2025 | 28 | 16 Jun 2022 |
1206825 | May 2025 | 28 | 03 Oct 2022 |
1208609 | Jun 2025 | 28 | 13 Dec 2022 |
1301062 | Sep 2025 | 28 | 09 Mar 2023 |
1301063 | Nov 2025 | 28 | 17 Jul 2023 |
1307545 | Jul 2026 | 28 | 06 Nov 2023 |
1309767 | Sep 2026 | 28 | 19 Mar 2024 |
1309768 | Sep 2026 | 28 | 09 Feb 2024 |
Product name: Atomoxetine 100mg Hard Capsules, PL 20075/1179
SNOMED Code: 37276111000001104
Batch Number | Expiry date | Pack size | First distributed |
1111229 | Aug 2024 | 28 | 13 Jan 2022 |
1206820 | May 2025 | 28 | 29 Sep 2022 |
1209117 | May 2025 | 28 | 30 Dec 2022 |
1210645 | Jun 2025 | 28 | 09 Oct 2023 |
1302718 | Jan 2026 | 28 | 08 Mar 2024 |
1302719 | Jun 2025 | 28 | 12 Jun 2023 |
Active Pharmaceutical Ingredient: Atomoxetine
Brief description of the problem
Accord Healthcare 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 batches 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 contact Accord-UK Ltd Medical Information Department on 01271 385257
For stock control enquiries please contact Accord- UK Ltd Customer Services Team on 0800 373573.