Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5 mg hard capsules. This decision comes in response to reports indicating capsule breakage during removal from the blister packaging, raising potential concerns among healthcare professionals and regulatory teams.
What changed?
On November 20, 2025, Sun Pharma announced a Class 3 recall for one batch of Fingolimod SUN 0.5mg capsules. The company emphasized the precautionary nature of the recall, noting that no other batches of the product have been impacted. Reports specifically flagged issues involving capsule breakage during extraction from blister packs.
Which batch is affected?
The recall concerns a single batch of Fingolimod SUN 0.5mg capsules distributed in the UK market. Sun Pharma has stated that customers should check packaging for the affected batch code to ensure compliance. It is vital to note that this recall does not extend to any additional batches or alternative Sun Pharma products.
Regulatory entities and clinical teams should review their stock immediately and follow outlined procedures for escalating these concerns to their internal quality assurance divisions.
What actions are required?
Healthcare teams, regulatory professionals, and pharmacists must evaluate inventory to identify the affected batch and promptly quarantine any flagged stock. Sun Pharma recommends reporting discrepancies or unresolved queries directly to their quality assurance department at the earliest. Clinical care providers are advised to inform patients receiving Fingolimod SUN capsules to ensure they experience no disruptions in treatment.
The Medicines and Healthcare products Regulatory Agency (MHRA) guidance further specifies that pharmacists and medical institutions must follow the recall protocols outlined by Sun Pharma. Additionally, regulatory teams should incorporate this update into internal safety databases to preclude future distribution errors.
FAQ
1. Why is the recall limited to one batch?
Investigations identified capsule breakage as an isolated issue affecting a specific batch. Sun Pharma has confirmed that no other batches are compromised.
2. How should healthcare professionals respond?
Professionals must isolate the affected batch inventory immediately and notify their internal quality assurance teams to initiate returns or dispose of flagged stock.
3. Does this recall affect patient treatments?
Patients should not experience disruptions if their healthcare providers adhere to recall protocols and provide alternative stock.
Recap
If your facility stocks Fingolimod SUN 0.5mg capsules, verify inventory against the affected batch code. Quarantine flagged stock and notify Sun Pharma or MHRA regarding compliance measures.
Sun Pharma’s recall ensures precautionary risk management for both medical professionals and patients relying on Fingolimod treatment.
Disclaimer
This announcement is intended for healthcare operators, pharmacists, and regulatory teams. It is not legal or clinical advice and does not replace detailed compliance documentation.
Announcement
For full information about the announcement, see the link below.