FDA Drug recall D-0569-2025
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sand…
- FDA Drug
- Class I
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class I recall of Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sand… by Sandoz, citing labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0569-2025 |
| 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
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Reason
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Identifiers
| ndc | 0781-3450-70 |
|---|---|
| ndc | 0781-3450-95 |
| ndc | 0781-3451-70 |
| ndc | 0781-3451-96 |
| ndc | 0781-3451-95 |
| 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.
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FDA Drug · Class II · 2025-09-17 · Sandoz - 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 · 2025-07-09 · Sandoz - Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-…
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0569-2025%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.