Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial,...

FDA Recall #D-0545-2025 — Class II — July 10, 2025

Recall #D-0545-2025 Date: July 10, 2025 Classification: Class II Status: Ongoing

Product Description

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

Recalling Firm

Pfizer Inc. — New York, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

19,279 vials

Distribution

Nationwide in the USA

Code Information

Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated