Quick answers
- What is Penicillin g used for?
- The FDA-approved label (Penicillin G Potassium, Baxter Healthcare Corporation, July 24, 2026) says: “Therapy Penicillin G Potassium Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Penicillin g have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Penicillin g?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Penicillin g been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 27, 2025 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Penicillin g?
- 9 companies list prescription products of Penicillin g in the FDA NDC Directory, including Roerig, WG Critical Care, LLC and Sandoz Inc.
What Penicillin g is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Therapy Penicillin G Potassium Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. …
— FDA label: Penicillin G Potassium, Baxter Healthcare Corporation, effective July 24, 2026. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Powder, for solution · Injection, solution |
|---|---|
| Route | Intravenous · Intramuscular · Intrapleural · Intrathecal |
| Prescription products | 21 in the FDA NDC Directory |
| Brand names | Pfizerpen |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Roerig6 products
- WG Critical Care, LLC3 products
- Sandoz Inc3 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Baxter Healthcare Corporation2 products
- Avenacy Inc.2 products
- Sagent Pharmaceuticals2 products
- NorthStar Rx LLC2 products
- Athenex Pharmaceutical Division, LLC.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050638 PENICILLIN G POTASSIUM IN PLASTIC CONTAINER | Baxter Hlthcare | June 25, 1990 | 14, latest November 2, 2023 2023: Labeling · 2017: Labeling · 2016: Labeling |
Generic approvals (5)
- ANDA060657Pfizer · August 30, 1968
- ANDA065068Sandoz · February 26, 2001
- ANDA065079Sandoz · August 30, 2002
- ANDA065149Hq Speclt Pharma · July 23, 2009
- ANDA065448Acs Dobfar Spa · August 18, 2009
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 27, 2025 · Class I · Ongoing · D-0570-2025
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
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. — Sandoz Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Penicillin G Potassium, Baxter Healthcare Corporation, effective July 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →