Recalls / Class I
Class ID-0570-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Penicillin G Potassium
- Generic name
- Penicillin G Potassium
- Active ingredient
- Penicillin G Potassium
- Route
- Intramuscular, Intravenous
- NDCs
- 0781-6135, 0781-6136
- FDA application
- ANDA065079
- Affected lot / code info
- Lot # PG4360, PG4362, Exp. 11/30/2027
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
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-06-27
- FDA classified
- 2025-08-06
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0570-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.