Pfizer Inc.: Drug Recall

Recall #D-0544-2025 · 07/10/2025

Class II: Risk

Recall Details

Recall Number: D-0544-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Pfizer Inc.
Status: Ongoing
Date Initiated: 07/10/2025
Location: New York, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50,855 2 mL vials

Reason for Recall

CGMP Deviations; particulates identified during visual inspection

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Pfizer Inc.

Class II: Risk 08/04/2025

Lack of Assurance of Sterility.
Class II: Risk 08/04/2025

Lack of Assurance of Sterility.
Class II: Risk 07/10/2025

CGMP Deviations; particulates identified during visual inspection
Class II: Risk 05/28/2025

Discoloration; discolored solution from cracked vials
Class II: Risk 05/20/2024

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

View all recalls by Pfizer Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.