Medicines recall

Allopurinol 100 mg tablets

Issued on 26 Aug 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency

Class 4 defect notification

Check the batch number on the pack. The medicine remains licensed; other batches are not affected.

Class 4 defect notification · 10 products · DMRC - 35766519 · PL: 28278/0035 · licence holder: Ipca Laboratories UK Limited · active ingredient: allopurinol · licence PL: 28278/0035

MHRA alert on GOV.UK ↗ All events: Allopurinol 100 mg tablets

What this means

The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.

Class 4 defect notification · DMRC - 35766519

Product	Licence	Active ingredient	GTIN
Allopurinol 100 mg tablets	PL: 28278/0035	allopurinol	18901079119732
Allopurinol 300 mg tablets	PL: 28278/0036	allopurinol	18901079119749
Amlodipine 5 mg Tablets	PL: 28278/0012	amlodipine besilate	05060777420024
Amlodipine 10mg Tablets	PL: 28278/0013	amlodipine besilate	05060777420031
Hydroxychloroquine sulfate 200 mg film-coated tablets	PL: 28278/0023	hydroxychloroquine sulfate	18901079116236
Levofloxacin 250mg Film Coated Tablets	PL: 28278/0001	levofloxacin Hemihydrate	05060777420413
Levofloxacin 500mg Film Coated Tablets	PL: 28278/0002	levofloxacin Hemihydrate	05060777420437
Gabapentin Ipca 100 mg Hard Capsules	PL: 28278/0098	gabapentin	05060777420666
Gabapentin Ipca 300 mg Hard Capsules	PL: 28278/0099	gabapentin	05060777420673
Gabapentin Ipca 400 mg Hard Capsules	PL: 28278/0100	gabapentin	05060777420680

Background: Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information. The errors were identified following a MHRA Good Pharmacovigilance Practice (GPvP) inspection and further investigation by the Marketing Authorisation Holder, Ipca Laboratories UK Ltd. This issue impacts all current batches of the impacted products. Please see the Appendices of the download document for detailed information regarding the missing information in each PIL. Appendix 1 - Allopurinol 100 mg tablets & Allopurinol 300 mg tablets Appendix 2 - Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets

Tracked from information published by the MHRA and the NHSBSA. This information is for guidance only and does not replace advice from your doctor or pharmacist.