FDA recall D-0545-2025

Product

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04

Reason for recall

CGMP Deviations; particulates identified during visual inspection

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-07-10

Report date

2025-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2025