Quick answers
- What is Albuterol sulfate used for?
- The FDA-approved label (Ventolin HFA, Remedyrepack Inc., January 19, 2026) says: “VENTOLIN HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Albuterol sulfate have a boxed warning?
- The label we quote has no boxed warning, but 3 of 100 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Albuterol sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Albuterol sulfate been recalled?
- FDA enforcement reports list 15 recalls of products of this medicine; the newest started July 24, 2025 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Albuterol sulfate?
- 42 companies list prescription products of Albuterol sulfate in the FDA NDC Directory, including Proficient Rx LP, NuCare Pharmaceuticals, Inc. and A-S Medication Solutions.
What Albuterol sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VENTOLIN HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. …
— FDA label: Ventolin HFA, Remedyrepack Inc., effective January 19, 2026. Read the full label on DailyMed →
The FDA has 100 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.
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.
3 of 100 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Aerosol, metered · Tablet · Inhalant · Syrup · Powder, metered |
|---|---|
| Route | Respiratory (inhalation) · Oral |
| Prescription products | 130 in the FDA NDC Directory |
| Brand names | Ventolin HFA, Albuterol Sulate HFA, Proair Respiclick, Proair Digihaler |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| albuterol sulfate 0.63 mg/3 mL solution | Generic | $0.1932–$0.2495 per mL 6 packages, lowest to highest |
| albuterol sulfate 0.83 mg/mL solution | Generic | $0.0600–$0.0654 per mL 6 packages, lowest to highest |
| albuterol sulfate 1.25 mg/3 mL solution | Generic | $0.1917–$0.2304 per mL 6 packages, lowest to highest |
| albuterol sulfate 108 ug aerosol, metered | Generic | $2.08 per gram |
| albuterol sulfate 2 mg tablet | Generic | $0.3124 per tablet |
| albuterol sulfate 2 mg/5 mL syrup | Generic | $0.0312 per mL |
| albuterol sulfate 2.5 mg/0.5 mL solution | Generic | $0.5200 per unit |
| albuterol sulfate 2.5 mg/3 mL solution | Generic | $0.0600–$0.0654 per mL 13 packages, lowest to highest |
| albuterol sulfate 4 mg tablet | Generic | $0.4469 per tablet |
| albuterol sulfate 90 ug aerosol, metered | Generic | $1.52–$2.08 per gram 6 packages, lowest to highest |
| albuterol sulfate 90 ug aerosol, metered | Brand: Ventolin HFA | $2.72–$3.03 per gram 2 packages, lowest to highest |
| albuterol sulfate 90 ug inhalant | Generic | $1.52–$2.08 per gram 5 packages, lowest to highest |
| albuterol sulfate 90 ug powder, metered | Brand: ProAir RespiClick | $67.16 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Proficient Rx LP10 products
- NuCare Pharmaceuticals, Inc.10 products
- A-S Medication Solutions8 products
- Preferred Pharmaceuticals Inc.8 products
- Remedyrepack Inc.8 products
- Chartwell RX, LLC7 products
- Rising Pharma Holdings, Inc.6 products
- Asclemed USA, Inc.6 products
- Aurobindo Pharma Limited5 products
- Sportpharm LLC4 products
- Ritedose Pharmaceuticals, LLC4 products
- Nephron Pharmaceuticals Corporation4 products
- Bryant Ranch Prepack3 products
- American Health Packaging3 products
- Mylan Pharmaceuticals Inc.3 products
- Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- HF Acquisition Co LLC, DBA HealthFirst3 products
- Amneal Pharmaceuticals NY LLC3 products
- Cipla USA Inc.2 products
- Ingenus Pharmaceuticals, LLC2 products
- Golden State Medical Supply, Inc.2 products
- Zydus Lifesciences Limited2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Teva Respiratory, LLC2 products
- Cardinal Health 107, LLC2 products
- Prasco Laboratories1 product
- Advanced Rx of Tennessee, LLC1 product
- GlaxoSmithKline LLC1 product
- Armstrong Pharmaceuticals, Inc.1 product
- Exelan Pharmaceuticals Inc.1 product
- Medical Purchasing Solutions, LLC1 product
- Padagis Israel Pharmaceuticals Ltd1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Quagen Pharmaceuticals LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- Sandoz Inc1 product
- Hawaii Repack, Inc.1 product
- Redpharm Drug1 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 |
|---|---|---|---|
| NDA020503 PROVENTIL-HFA | Kindeva | August 15, 1996 | 30, latest September 22, 2017 2017: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
| NDA020983 VENTOLIN HFA | Glaxosmithkline | April 19, 2001 | 17, latest August 18, 2021 2021: Labeling · 2019: Labeling · 2015: Manufacturing (CMC) |
| NDA021457 PROAIR HFA | Teva Branded Pharm | October 29, 2004 | 15, latest February 25, 2019 2019: Labeling · 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA205636 PROAIR DIGIHALER, PROAIR RESPICLICK | Teva Branded Pharm | March 31, 2015 | 10, latest August 28, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
Generic approvals (25)
- ANDA072637Sun Pharm Industries · February 1, 1989
- ANDA072151Chartwell Rx · March 23, 1989
- ANDA074880Nephron · September 17, 1997
- ANDA075664Nephron · June 26, 2001
- ANDA076355Nephron · June 28, 2004
- ANDA077788Chartwell Rx · June 26, 2007
- ANDA077839Ritedose Corp · December 16, 2008
- ANDA207857Sun Pharm · July 21, 2017
- ANDA206224Luoxin Aurovitas · October 17, 2017
- ANDA208804Amneal Pharms Co · May 21, 2018
- ANDA207046Rising · June 29, 2018
- ANDA212197Quagen · September 6, 2019
- ANDA203760Padagis Us · February 24, 2020
- ANDA209959Cipla · April 8, 2020
- ANDA211888Luoxin Aurovitas · April 20, 2020
- ANDA213657Aurobindo Pharma Ltd · May 14, 2020
- ANDA209954Lupin · August 24, 2020
- ANDA208884Zydus Pharms · October 22, 2020
- ANDA207085Sandoz · June 1, 2021
- ANDA214531Ritedose Corp · December 28, 2021
- ANDA215571Lexenpharm · May 3, 2024
- ANDA212447Armstrong Pharms · May 21, 2024
- ANDA218386Ritedose Corp · March 12, 2025
- ANDA211600Amneal Ireland Ltd · December 1, 2025
- ANDA219409Cipla · April 22, 2026
Shortage status
Shortage resolved · updated August 27, 2026 · first posted October 25, 2022
| Product | Albuterol Sulfate, Solution, 2.5 mg/.5 mL (NDC 64980-642-03) |
|---|---|
| Company | Rising Pharma Holdings, Inc. |
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.
-
July 24, 2025 · Class III · Ongoing · D-0593-2025
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 — Cipla USA, Inc.
-
June 27, 2023 · Class I · Terminated · D-0938-2023
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 1 — Cipla USA, Inc.
-
April 13, 2022 · Class II · Terminated · D-1024-2022
cGMP deviations: Temperature abuse
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1018-2022
cGMP deviations: Temperature abuse
Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1020-2022
cGMP deviations: Temperature abuse
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1019-2022
cGMP deviations: Temperature abuse
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03 — Mckesson Medical-Surgical Inc. Corporate Office
-
January 26, 2022 · Class II · Terminated · D-0163-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 4 — CARDINAL HEALTHCARE
-
January 26, 2022 · Class II · Terminated · D-0162-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68 — CARDINAL HEALTHCARE
-
September 16, 2020 · Class II · Terminated · D-1594-2020
Defective Delivery System: Sustained trend of failure to dispense complaints.
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 4 — Perrigo Company PLC
-
May 16, 2017 · Class II · Ongoing · D-0793-2017
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20. — GlaxoSmithKline, LLC
-
March 22, 2017 · Class II · Ongoing · D-0626-2017
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20. — GlaxoSmithKline, LLC
-
December 3, 2015 · Class II · Terminated · D-0519-2016
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 — GlaxoSmithKline, LLC
-
October 2, 2013 · Class II · Terminated · D-66462-001
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487 — Nephron Pharmaceuticals Corp.
-
July 26, 2012 · Class II · Terminated · D-1666-2012
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Tri — GlaxoSmithKline Inc
-
June 22, 2011 · Class II · Terminated · D-1446-2012
Lack of Assurance of Sterility
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 3281 — Nephron Pharmaceuticals Corp.
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) — Ventolin HFA, Remedyrepack Inc., effective January 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 →