RecallRadar

FDA Drug recall D-0544-2025

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…

On 2025-08-06 the FDA classified a Class II recall of 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… by Pfizer, citing CGMP Deviations; particulates identified during visual inspection.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0544-2025
ClassificationClass II
Statusongoing
Initiated2025-07-10
Published2025-08-06
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionUS

Product

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

CGMP Deviations; particulates identified during visual inspection

Identifiers

ndc60793-700-01
ndc60793-700-10
ndc60793-701-02
ndc60793-701-10
ndc60793-702-04
ndc60793-702-10
code_infoLots: 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 history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0544-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.