Buffered Penicillin G Potassium for Injection recall
FDA recall D-0570-2025 · initiated Jun 27, 2025
Sandoz Inc recalled Buffered Penicillin G Potassium for Injection in Jun 2025 — an FDA Class I recall (D-0570-2025) because 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.
Most serious — a reasonable probability that use will cause 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
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: unknown
Details
- 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.
- Recalling company
- Sandoz Inc
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 27, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was Buffered Penicillin G Potassium for Injection recalled?
- Sandoz Inc recalled Buffered Penicillin G Potassium for Injection in Jun 2025 — an FDA Class I recall (D-0570-2025) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Buffered Penicillin G Potassium for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0570-2025 was: 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
- Is a recalled Buffered Penicillin G Potassium for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Buffered Penicillin G Potassium for Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # PG4360, PG4362, Exp. 11/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0570-2025.