Summary
Théa Pharma S.A. is recalling six batches of Lacrycon eye gel in single doses (20 × 0.65 ml) from the market in coordination with Swissmedic as a precautionary measure. The affected batches are 6V55, 7V27, 7V91, 1X27, 9V84, and 2X79. The reason for the recall is a possible microbial contamination during production. To date, no adverse effects or complaints have been reported. Patients should not use affected packages and should return them to their doctor's office or pharmacy.
People
- Théa Pharma S.A. (Manufacturer; Customer Service)
- Swissmedic (Swiss Institute for Medicinal Products)
Topics
- Pharmaceutical Safety
- Quality Defects
- Batch Recalls
- Ophthalmology
Clarus Lead
The precautionary recall underscores the effectiveness of Swiss pharmaceutical surveillance: Swissmedic and the manufacturer are responding proactively to production defects before patients are harmed. For users of Lacrycon, immediate action is required – returning affected batches to pharmacies or doctor's offices prevents potential infection risks.
Detailed Summary
The recall action affects exclusively the eye gel in the single-dose package with 20 doses of 0.65 ml each. Other dosage forms or package sizes of Lacrycon are not affected. The production defect was identified at the manufacturer's facility before greater damage could occur.
Patients who possess one of the six batches should no longer use it and should immediately return it to their pharmacy or doctor's office. The manufacturer provides customer service for questions ([email protected]). Detailed information is available in the information letter from Théa Pharma and on the Swissmedic website.
Key Points
- Six batches of Lacrycon eye gel in single doses are being recalled due to possible microbial contamination
- No adverse effects or complaints have been reported in patients to date
- Recall is precautionary and coordinated between the manufacturer and Swissmedic
- Patients should immediately stop using affected packages and return them
Critical Questions
Evidence: What testing methods support the diagnosis of microbial contamination, and were all six batches systematically tested or only individual ones?
Conflicts of Interest: How long was the production defect known to the manufacturer before the recall was initiated, and were there delays in reporting to Swissmedic?
Causality: Were patients who used Lacrycon from these batches systematically followed up to rule out subclinical infections?
Feasibility: How is it ensured that all patients in doctor's offices and pharmacies are informed of the recall, and what deadline applies for returns?
Adverse Effects: What type of microbial pathogens were identified, and what infection risks exist specifically for eye applications?
Quality Control: Were production processes at Théa Pharma reviewed to exclude similar contaminations in future batches?
References
Primary Source: Swissmedic – Batch Recall Lacrycon Eye Gel Single Doses – https://www.news.admin.ch/de/newnsb/YuPMxhcq6OFIVZqUI4_Zb
Supplementary Sources:
- Théa Pharma S.A. – Information Letter Lacrycon – https://cms.news.admin.ch/dam/de/bfk/wPffWscBIw1O/20260416_recall+letter_DE+final.pdf
- Swissmedic – Market Surveillance Batch Recalls – https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/marktueberwachung/qualitaetsmaengel-und-chargenrueckrufe/chargenrueckrufe/chargenrueckruf-lacrycon-augengel-einzeldosen.html
Verification Status: ✓ 17.04.2026
This text was created with the support of an AI model. Editorial Responsibility: clarus.news | Fact-Check: 17.04.2026