FDA Recall D-0545-2025

Pfizer Inc. · New York, NY

Class II Ongoing 308 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.

Quantity: 19,279 vials

Reason for recall

CGMP Deviations; particulates identified during visual inspection

Recall record

Recall number: D-0545-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-07-10
Classified by FDA Center: 2025-07-30
FDA published: 2025-08-06
Recalling firm: Pfizer Inc.
Firm location: New York, NY

Drug identification

Brand name(s): BICILLIN L-A
Generic name(s): PENICILLIN G BENZATHINE
Manufacturer(s): Pfizer Laboratories Div Pfizer Inc
NDC(s): 60793-700, 60793-701, 60793-702
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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