← FDA ENFORCEMENT
D-0544-2025Class II

Pfizer Inc.

Recalling firm
Pfizer Inc.
Product type
Drug
Status
Ongoing
Report date
2025-08-06
Distribution
Nationwide in the USA
Firm state
NY
Product quantity
50,855 2 mL vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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

Code / lot 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;

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.