Who Owns Tirosint?

IBSA publishes sustainability reports under European Sustainability Reporting Standards (ESRS). The company's seventh report, covering 2024, addresses environmental monitoring, supply chain resilience, and corporate social responsibility.

IBSA has implemented environmental monitoring systems across its manufacturing facilities in Switzerland and Italy. The company reports on energy usage, waste management, and water quality at its production sites. However, IBSA has not published specific carbon reduction targets or net-zero commitments.

Tirosint is manufactured under cGMP regulations with FDA oversight. The FDA conducted an inspection of IBSA's manufacturing practices as part of its ongoing post-market surveillance. No manufacturing compliance issues have been publicly disclosed for the Tirosint capsule formulation.

IBSA introduced a corporate volunteering program in 2024 and reports on employee well-being initiatives. The company's ESRS reporting covers social responsibility topics including patient engagement, medical professional education, and community impact.

Tirosint has not received traditional consumer product awards, which is typical for prescription pharmaceuticals. Its recognition comes from regulatory approvals and clinical adoption:

• FDA approval of Tirosint capsules in 2006 (NDA 021924) represented the first levothyroxine softgel capsule formulation in the US market
• FDA approval of Tirosint-SOL in 2017 (NDA 207976) expanded the franchise with a liquid formulation offering 15 strengths
• IBSA's softgel capsule technology has been recognized in pharmaceutical industry literature for improving oral medication delivery and patient compliance
• Tirosint is included in clinical guidelines for hypothyroidism management, particularly for patients with documented absorption issues or excipient sensitivities

Tirosint has experienced one significant product recall:

• Tirosint-SOL voluntary recall (January 2023): IBSA Pharma announced a voluntary recall of 27 lots of Tirosint-SOL (levothyroxine sodium oral solution) due to potential subpotency. The recall affected only the liquid formulation, not the softgel capsules. The FDA classified it as a Class I recall, the most serious category, because subpotent levothyroxine could cause patients to experience hypothyroid symptoms including fatigue, cold sensitivity, constipation, dry skin, and weight gain. IBSA Pharma reported no adverse events related to the recall. The company notified wholesalers, retailers, and healthcare providers to stop distributing the affected lots and established a patient hotline at 1-800-587-3515. Patients were advised to continue taking their medication until consulting their healthcare provider.
• Pharmacy-level availability issues (ongoing): While not a formal recall, Tirosint has faced persistent availability problems at retail pharmacies. As of early 2026, the medication is not listed on FDA or ASHP shortage databases, but many pharmacies do not consistently stock it due to low prescription volume. This has created practical challenges for patients, some of whom have been forced to switch pharmacies or use mail-order services. IBSA has not reported manufacturing disruptions, and the Tirosint Direct mail order program provides an alternative supply channel.