Bicillin L-A — Class II drug recall D-0545-2025
Ongoing recall by Pfizer Inc., reported 2025-08-06, distributed nationwide. CGMP Deviations; particulates identified during visual inspection
| Recall number | D-0545-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2025-07-10 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 19,279 vials |
| Reason classes | cgmp, specification failure |
| NDC | 60793-0700, 60793-0700-01, 60793-0700-10, 60793-0701, 60793-0701-02, 60793-0701-10, 60793-0702, 60793-0702-04, 60793-0702-10 |
| Lot numbers | GT2598, GT2599, HK2909, HR9969, HR9984 |
| Expiration dates | 2026-09-30, 2027-02-28, 2027-04-30, 2027-08-31 |
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 for recall
CGMP Deviations; particulates identified during visual inspection
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0545-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.