Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Buffered Penicillin G Potassium for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
0781-6136-94
Compare with the code on your package — it is the most precise check available.
Drug: Penicillin Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Penicillin G Potassium NDC 00781-6136 |
20000000 [iU]/1 | Injection, Powder, for Solution Intramuscular|intravenous |
Sandoz Inc | Rx |
- Recalling firm
- Sandoz Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0570-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Penicillin recalls
See all
Class II · Moderate risk
Bicillin L-A
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Penicillin
Lack of sterility assurance
Class II · Moderate risk
Penicillin V Potassium for Oral Solution
Subpotent
Class II · Moderate risk
PENICILLIN V POT for Oral Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Sandoz Inc
All 2025 recalls
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class I · High risk
Cefazolin for Injection
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
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.