Quick answers
- What is Aminophylline used for?
- The FDA-approved label (Aminophylline, HF Acquisition Co LLC, DBA HealthFirst, June 19, 2026) says: “Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Aminophylline have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Aminophylline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aminophylline been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 27, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Aminophylline?
- 5 companies list prescription products of Aminophylline in the FDA NDC Directory, including Hospira, Inc., Medical Purchasing Solutions, LLC and Henry Schein, Inc..
What Aminophylline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
— FDA label: Aminophylline, HF Acquisition Co LLC, DBA HealthFirst, effective June 19, 2026. Read the full label on DailyMed →
The FDA has 6 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 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 9 in the FDA NDC Directory |
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.
- Hospira, Inc.2 products
- Medical Purchasing Solutions, LLC2 products
- Henry Schein, Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- ProPharma Distribution1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA087242Hospira · October 26, 1983
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.
-
September 27, 2022 · Class II · Terminated · D-0003-2023
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton) — Pfizer 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
| RxCUI (RxNorm) | 1724666, 1724668 |
|---|---|
| SPL set ID of the quoted label | 819207a2-0c37-b275-e053-2a91aa0afb36 |
| FDA labels (SPL) | 6 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | AMINOPHYLLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aminophylline, HF Acquisition Co LLC, DBA HealthFirst, effective June 19, 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 →