New health alert in Spain. The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has ordered the withdrawal of several eye drops used to treat both ocular allergies and dry eyes. The notice has arrived recently and affects different medicines with quality defects detected during controls. The eye drops affected by the recall notice are mainly the Ikervis brand (1 mg) and Ibis (6 mg).
As reported AEMPS itselfthe problems detected do not pose a life-threatening risk to patients. Of course, as a precautionary measure, the usual protocol has been activated, which involves the immediate withdrawal of the affected batches and their return to the laboratories, with the supervision of the autonomous communities.
These alerts also coincide with the beginning of the allergy season, when the use of this type of eye drops increases significantly among the population.
These are the eye drops withdrawn by Health
The AEMPS has pointed out several medications affected by these incidents, all of them related to eye treatments:
Ikervis 1 mg/ml (eye drops emulsion)
- Lot: 4T92E
- Presentation: 30 single-dose containers of 0.3 ml
- Use: treatment of severe keratitis associated with dry eye
Ibis 6 mg/ml (antihistamine eye drops for allergies)
- Lots: 2956008 (expiry 06/30/2026), 313160A (01/31/2027), 3131908 (12/31/2026)
- Use: treatment of seasonal allergic conjunctivitis and other eye allergies
In the case of Ibis, this is the second alert in a few days related to allergy eye drops, and both share a manufacturing laboratory in Spain.
What problem do medications have?
Eye drops are a sterile liquid solution or suspension that is applied directly by drops to the conjunctival sac of the eye and is used to treat ocular conditions (infections, inflammation, glaucoma) or to lubricate and hydrate the ocular surface (artificial tears. Therefore, due to its direct contact with a surface as delicate as the eye, it is not recommended to use it if it has any of the following defects:
- In Ikervis, a “result outside specifications” has been identified in the amount of active ingredient (cyclosporine).
- In Ibis, the problem is due to the presence of subvisible particles detected during drug stability studies.
Both cases have been classified as Class 2 quality defects, which implies that they do not represent a serious health risk, but do require preventive withdrawal from the market.
What are these eye drops used for?
The affected medications are indicated for different common eye problems:
- Ikervis: contains cyclosporine, an immunosuppressant that reduces inflammation in the cornea. It is used in severe cases of dry eye that do not improve with artificial tears.
- Ibis: contains bilastine, an antihistamine that blocks the effects of histamine and relieves the symptoms of allergic conjunctivitis, such as itching, redness or watering.
What patients should do
Health recommends that people who have at home any of the batches of eye drops affected by any of the problems described above, do the following:
- Check the lot number on the packaging.
- Do not use the product if it matches those recalled.
- Go to your pharmacy for a return or to receive information.
For the rest of the population, the use of these medications outside of the designated batches does not present any problem.