FDA Drug recall D-0545-2025
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New… by Pfizer, citing CGMP Deviations; particulates identified during visual inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0545-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-10 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
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
Reason
CGMP Deviations; particulates identified during visual inspection
Identifiers
| ndc | 60793-700-01 |
|---|---|
| ndc | 60793-700-10 |
| ndc | 60793-701-02 |
| ndc | 60793-701-10 |
| ndc | 60793-702-04 |
| ndc | 60793-702-10 |
| code_info | Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-08-06 · Pfizer
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0545-2025%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.