Drug FDA Class II Ongoing Foreign material

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

Pfizer Inc. Published Aug 6, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Pfizer Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

CGMP Deviations; particulates identified during visual inspection

Hazards

Particulate Matter · primary

Affected products (1)

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

BICILLIN L-A · 50,855 2 mL vials

NDC: 60793-700, 60793-701, 60793-702, 60793-700-01, 60793-700-10, 60793-701-02, 60793-701-10, 60793-702-04, 60793-702-10

Code info: 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 areas

Nationwide

Timeline

Initiated

Jul 10, 2025
Published

Aug 6, 2025

Recall number: D-0544-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.