Pfizer Issues Voluntary Recall Of Bicillin L-A

Pfizer issued a voluntary drug recall for select lots of Bicillin L-A and provided a supply update on July 10 due to particulates identified during visual inspection. Pfizer anticipates a near-term stockout for indicated products, and company representatives stated they will provide a production update no later than mid-August. 

During this interim period, Pfizer is implementing its Medical Request Process to ensure the product is distributed equitably to hospitals and clinics treating patients with the highest medical necessity. On July 14, the FDA revised a drug shortage notice for Bicillin, indicating delay in shipment of the drug as the reason for the shortage.

This recall and potential shortage are of particular concern as Bicillin L-A is the only drug recommended for the treatment of syphilis during pregnancy. For other uses of Bicillin L-A, such as treatment of strep throat or other bacterial infections, alternatives such as doxycycline can be used.

Treatment of syphilis in pregnant individuals is critical to prevent the spread of infection to the newborn, also known as congenital syphilis. If not treated, syphilis during pregnancy can cause low birth weight, miscarriage, stillbirth and other adverse effects in newborns. Increased rates of congenital syphilis may be further complicated by the potential shortage of Bicillin, especially with the antibiotic being a key part of the strategy to attempt to reduce rates. 

Missouri has seen a sharp increase in rates of congenital syphilis since 2019, with the Missouri Department of Health and Senior Services issuing a health update in February 2024.