Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial,...

FDA Recall #D-0544-2025 — Class II — July 10, 2025

Recall #D-0544-2025 Date: July 10, 2025 Classification: Class II Status: Ongoing

Product Description

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

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

50,855 2 mL vials

Distribution

Nationwide in the USA

Code Information

Lots: HJ3235, Exp 09/30/26; GL2954, HP6222, Exp, 01/31/27; HR9967, Exp 05/31/27; HP6232, LT5190,Exp 09/30/27; HP6228, Exp 10/31/27;

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated