News and Articles

• A manufacturer transition has caused a shortage of erythromycin ophthalmic ointment, the only FDA-approved product for newborn ophthalmia neonatorum prophylaxis.
• Health authorities are recommending azithromycin ophthalmic ointment as a temporary alternative, though it lacks the same approved newborn prophylaxis indication.
• Erythromycin lactobionate injection remains on extended back order, with release not expected until the third quarter of 2026.
• Professional ophthalmology and surgery organizations have issued joint clinical guidance to help providers manage the supply gap.
• Hospital procurement teams should assess inventory immediately and coordinate with health authorities on allocation priorities for maternity and newborn care units.

A shortage of erythromycin ophthalmic ointment has emerged following a change in manufacturer responsibility for the product, creating supply disruption for a medication with no approved substitute for its primary indication. The ointment is the only product currently approved for the prophylaxis of ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis, a standard preventive treatment administered to newborns shortly after birth in hospitals across the country. The shortage originated as one pharmaceutical company acquired manufacturing and distribution rights from another, with the new rights holder working alongside an established ophthalmic manufacturer to scale up production capacity to meet ongoing clinical demand.

Health authorities have responded to the shortage by recommending azithromycin ophthalmic ointment as an alternative for general ophthalmic indications where erythromycin would typically be used, though azithromycin lacks the same explicit regulatory approval for newborn prophylaxis that erythromycin carries. Professional medical organizations focused on ophthalmology and cataract and refractive surgery have jointly issued guidance to clinicians managing the supply gap, reflecting the clinical significance of maintaining uninterrupted access to appropriate prophylactic treatment for newborns at risk of serious eye infections.

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Compounding the supply challenge, erythromycin lactobionate injection, a separate formulation used in broader infection treatment contexts, remains on extended back order from at least one large supplier, with an estimated release date pushed to the third quarter of 2026. This longer-duration shortage affects hospital pharmacies managing erythromycin as part of treatment protocols for patients with penicillin allergies or specific bacterial infections where the macrolide antibiotic class offers clinical advantages over alternative therapies.

The erythromycin supply disruption illustrates a broader vulnerability in pharmaceutical manufacturing where a small number of producers supply essential medications with limited substitutability. When manufacturer transitions occur, even ones intended to ultimately expand or stabilize supply, the transition period itself can create gaps that ripple through hospital and pharmacy procurement systems nationally. The newborn prophylaxis indication is particularly sensitive given the absence of a fully equivalent regulatory-approved alternative, placing pressure on hospital systems to manage existing inventory carefully while production scales back up.

For hospital and health system procurement teams, the current erythromycin shortage calls for immediate inventory assessment and coordination with regional health authorities on allocation priorities, particularly for maternity and newborn care units where the ophthalmic ointment is a standard-of-care requirement. Pharmacy teams managing the injectable lactobionate formulation should plan for continued unavailability through at least the third quarter and confirm alternative macrolide protocols with clinical staff where appropriate.