CLASS I ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
Buffered Penicillin G Potassium for Injection recalled by Sandoz
Sandoz is recalling Buffered Penicillin G Potassium for Injection, USP (20 million units), For IV use, Sterile, distributed nationwide in the US. The recall was initiated on 27 Jun 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0570-2025
- FDA event ID
- 97140
- Recalling firm
- Sandoz, Princeton, NJ
- Manufacturer
- Sandoz Inc
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Jun 2025
- FDA classified
- 6 Aug 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Antibiotics
Timeline
| 27 Jun 2025 | Recall initiated by company | |
| 9 Jul 2025 | Published in enforcement report | +12 days |
| 6 Aug 2025 | Classified by FDA | +28 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot # PG4360, PG4362, Exp. 11/30/2027
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97140This product is part of a recall event; the main page for the event is Cefazolin for Injection, USP per vial, Sterile recalled by Sandoz.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalledOrphenadrine Citrate | Sandoz | Nitrosamine Impurity | Nationwide |