Buffered Penicillin G Potassium for Injection — Class I drug recall D-0570-2025
Ongoing recall by Sandoz Inc, reported 2025-07-09, distributed nationwide. Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicill
| Recall number | D-0570-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2025-06-27 |
| Classified | 2025-08-06 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 00781-6135, 00781-6135-94, 00781-6135-95, 00781-6136, 00781-6136-94 |
| Lot numbers | PG4360, PG4362 |
| Expiration dates | 2027-11-30 |
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 for recall
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
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-0570-2025. 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.