BICILLIN L-A
Recalling Firm / Manufacturer: Pfizer Inc.
(New York, NY, United States)
FDA Recall Number: D-0544-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
BICILLIN L-A
Generic Name
PENICILLIN G BENZATHINE
Active Substance(s)
Penicillin G Benzathine
Administration Route
Intramuscular
National Drug Code (NDC)
60793-700
Total Quantity Recalled
50,855 2 mL vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
CGMP Deviations; particulates identified during visual inspection
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
August 06, 2025
Firm Initiation Date
July 10, 2025
FDA Classification Date
Jul 30, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
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;
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0544-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508615UTCC