Pfizer Warns of ‘Near-Term Stock Out’ of Penicillin Used for Treating Syphilis in Pregnant Women After Recall
Pfizer issued a voluntary recall on July 10, 2025, for multiple lots of Benzathine penicillin G (Bicillin L-A), impacting supplies nationwide due to particulate contamination discovered during inspection123.
The U.S. Food and Drug Administration (FDA) declared a drug shortage alert for Bicillin L-A following the recall, warning that normal supply restoration is uncertain, with shortages expected to continue for an extended period135.
Pfizer has warned healthcare providers to expect a 'near-term stock out' of Bicillin L-A, the preferred and only recommended treatment for syphilis during pregnancy, raising concerns about rising rates of congenital syphilis123.
Healthcare providers are advised by the CDC and FDA to prioritize remaining Bicillin L-A supplies for pregnant individuals and infants with congenital syphilis while considering alternatives (such as Extencilline and doxycycline) for non-pregnant patients135.
Recent CDC surveillance data show a marked increase (203% rise in five years) in congenital syphilis cases in the U.S., making this shortage a critical public health issue1.
No reports of adverse events related to the contaminated recalled lots have been received so far2.
The shortage is projected to persist, with supply recovery not expected until at least the fourth quarter of 2024, according to provider advisories5.
Sources:
1. https://www.nmhealth.org/publication/view/general/9308/
2. https://www.wbrz.com/news/wednesday-s-health-report-pfizer-recalls-injected-penicillin-used-to-treat-syphilis-in-pregnant-women
3. https://www.sandiegocounty.gov/content/dam/sdc/hhsa/programs/phs/cahan/communications_documents/7.16.2025.pdf
5. https://www.slocounty.ca.gov/departments/health-agency/public-health/forms-documents/for-healthcare-providers/provider-notices/7-15-2025-bicillin%C2%AE-l-a-recall-and-national-shortage