Albuterol is a beta2-adrenergic agonist sold in the U.S. under 10 brand and generic names, for asthma and bronchial spasm. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Proair Digihaler (application NDA205636). Other albuterol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours by oral inhalation. In some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise by oral inhalation. (2.2) PROAIR RESPICLICK does not require priming. ( 2.3 ) Do not use with a spacer or volume holding chamber. ( 2.3 ) Keep the inhaler clean and dry at all times. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water. ( 2.3 ) Discard 13 months after opening the foil pouch, when the dose counter displays 0, or after the expiration date on the product, whichever comes first. ( 2.3 ) 2.1 Recommended Dosage for Bronchospasm The recommended dosage is 2 inhalations every 4 to 6 hours by oral inhalation. More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient. 2.2 Recommended Dosage for Exercise-Induced Bronchospasm The recommended dosage is 2 inhalations 15 to 30 minutes before exercise by oral inhalation. 2.3 Administration and Maintenance Information Administer PROAIR…
Use of PROAIR RESPICLICK may be associated with the following: Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )] Cardiovascular Effects [see Warnings and Precautions ( 5.4 )] Immediate hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] Hypokalemia [see Warnings and Precautions ( 5.8 ) Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience A total of 1289 subjects were treated with PROAIR RESPICLICK during the clinical development program. The most common adverse reactions (≥1% and > placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults and Adolescents 12 years of Age and Older : The adverse reaction information presented in Table 1 below concerning PROAIR RESPICLICK is derived from the 12-week blinded treatment period of three studies…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Spray/Inhaler | Generic | $11 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Nephron SC, LLC · Mar 17, 2026
Albuterol Sulfate
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.
Cipla USA, Inc. · Jul 24, 2025
Airsupra (albuterol and budesonide) inhalation aerosol
Defective delivery system
AsttraZeneca Pharmaceuticals LP · May 14, 2025
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Cipla USA, Inc. · Mar 26, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
PROAIR RESPICLICK is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see Warnings and Precautions ( 5.6 )] . Patients with hypersensitivity to albuterol. ( 4 ) Patients with severe hypersensitivity to milk proteins. ( 4 )
Other short-acting sympathomimetic bronchodilators should not be used concomitantly with PROAIR RESPICLICK. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. ( 7 ) Beta-blockers: May decrease effectiveness of PROAIR RESPICLICK and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ( 7.1 ) Diuretics, or non-potassium sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels. ( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.3 ) Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. ( 7.4 ) 7.1 Beta-Blockers Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROAIR RESPICLICK, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, eg, as prophylaxis after myocardial infarction, there may be no acceptable alternatives to…
| $11 |
| View → |
| 3 | 70/100 | Prescription | Capsule | Generic | $11 | View → |
| 4 | Not yet rated | Prescription | Solution | Generic | $11 | View → |
| 5 | Not yet rated | Prescription | Spray/Inhaler | Generic | $11 | View → |
| 6 | Not yet rated | Prescription | Spray/Inhaler | Generic | $11 | View → |
| 7 | Not yet rated | Prescription | Powder | Generic | $11 | View → |
| 8 | Not yet rated | Prescription | Solution | Generic | $11 | View → |
| 9 | Not yet rated | Prescription | Spray/Inhaler | Generic | $11 | View → |
| 10 | Not yet rated | Prescription | Tablet | Generic | $11 | View → |