Recalls / Class II
Class IID-0545-2025
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
- Brand name
- Bicillin L-a
- Generic name
- Penicillin G Benzathine
- Active ingredient
- Penicillin G Benzathine
- Route
- Intramuscular
- NDCs
- 60793-700, 60793-701, 60793-702
- FDA application
- NDA050141
- Affected lot / code info
- Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Why it was recalled
CGMP Deviations; particulates identified during visual inspection
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 19,279 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-07-10
- FDA classified
- 2025-07-30
- Posted by FDA
- 2025-08-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0545-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.