Bicillin L-a Injection, Suspension
FDA Recall NDC 60793-700
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Bicillin L-a (NDC 60793-700). A significant event, classified as Class II, was initiated on Jul 10, 2025 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "CGMP Deviations; particulates identified during visual inspection"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
July 2025 Class II Recall: CGMP Deviations; particulates identified during visual inspection
Recall Number
Class II Ongoing
CGMP Deviations; particulates identified during visual inspection
Jul 10, 2025
Aug 06, 2025
19,279 vials
Recall Profile & Regulatory Data
Event ID
97220
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Affected Packages Involved in this Recall
60793-700-01Product
60793-700-10Product
60793-701-02Product
60793-701-10Product
60793-702-04Product
60793-702-10Product
July 2025 Class II Recall: CGMP Deviations; particulates identified during visual inspection
Recall Number
Class II Ongoing
CGMP Deviations; particulates identified during visual inspection
Jul 10, 2025
Aug 06, 2025
50,855 2 mL vials
Recall Profile & Regulatory Data
Event ID
97220
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
60793-700-01Product
60793-700-10Product
60793-701-02Product
60793-701-10Product
60793-702-04Product
60793-702-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
