# BCG vaccine suspension in Southeast Europe > Live situation record from CLSTR: https://clstr.news/situations/bcg-vaccine-suspension-in-southeast-europe > Updated: 2026-10-07T12:51:22.000Z. Sources: 68. Developments: 2. Health authorities in Croatia, North Macedonia, and Bosnia and Herzegovina have suspended the distribution and use of the BCG tuberculosis vaccine produced by Bulgarian manufacturer Bul Bio NCIPD Ltd. The suspension follows reports from the Croatian Medicines Agency (HALMED) regarding four suspected cases of osteomyelitis—a rare bone infection—in children vaccinated during 2024 and early 2025. The Bulgarian manufacturer has rejected claims of quality issues, asserting that an internal investigation found that in two of the four Croatian cases, a dose ten times higher than the prescribed amount was administered. However, Croatian health officials, including Krunoslav Capak, have suggested this may be a data entry error in the European database, where ‘0.5 ml might have been recorded instead of the correct 0.05 ml’. In Bosnia and Herzegovina, the Agency for Medicines and Medical Devices (ALMBiH) reported that all vaccine batches imported in 2026 passed quality controls, noting that no adverse reactions have been reported in the country since 2020. Montenegro has also clarified that the specific batches under investigation in Croatia were not distributed in its country and that no adverse reactions have been reported locally. ## Claims - The Bulgarian manufacturer Bul Bio claims its internal investigation found that in two cases, a dose ten times higher than prescribed was administered. (disputed by 2 sources) - Krunoslav Capak suggested the reported ten-fold overdose might be a data entry error in the European database, where 0.5 ml was entered instead of 0.05 ml. (disputed by 2 sources) - The Croatian agency HALMED has not confirmed that incorrect doses were administered in the four suspected cases of osteomyelitis. (corroborated by 3 sources) - Croatia has suspended the distribution and use of all batches of the Bul Bio BCG vaccine following four reports of suspected osteomyelitis. (corroborated by 2 sources) - Montenegro confirmed that the specific batches of the Bulgarian BCG vaccine suspended in Croatia were never distributed in Montenegro. (corroborated by 2 sources) - The Bulgarian manufacturer Bul Bio has rejected claims regarding quality issues with its BCG vaccine. (corroborated by 2 sources) - The Agency for Medicines and Medical Devices of Bosnia and Herzegovina stated that all BCG vaccine batches imported in 2026 passed quality controls. (single source) - Croatia, North Macedonia, and Bosnia and Herzegovina have implemented preventive measures to suspend the use or distribution of the Bulgarian BCG vaccine. (single source) ## Timeline ### 2026-10-07: Bulgarian BCG vaccine suspended in several Balkan countries Croatia, Bosnia and Herzegovina, and North Macedonia have suspended the Bulgarian-made BCG vaccine following suspected adverse reactions in Croatia, amid investigations into potential dosing errors. 24 sources. https://clstr.news/cluster/montenegro-confirms-bcg-vaccine-batches-used-are-not-those-suspended-in-croatia ### 2026-10-05: BCG vaccine suspension in Croatia and neighboring regions Croatia, North Macedonia, and Republika Srpska have suspended the Bulgarian-made BCG vaccine following four suspected cases of osteomyelitis in children, pending quality investigations. 54 sources. https://clstr.news/cluster/croatia-suspends-bcg-vaccine-use-following-reports-of-bone-infection --- Cite as: BCG vaccine suspension in Southeast Europe. CLSTR, https://clstr.news/situations/bcg-vaccine-suspension-in-southeast-europe