FDA Drug recall D-0570-2025
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austr…
- FDA Drug
- Class I
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class I recall of Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austr… by Sandoz, citing labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0570-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-06-27 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Reason
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Identifiers
| ndc | 0781-6135-94 |
|---|---|
| ndc | 0781-6135-95 |
| ndc | 0781-6136-94 |
| code_info | Lot # PG4360, PG4362, Exp. 11/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0570-2025%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.