CLASS II Drug recall · Reported 16 Dec 2015 · FDA Enforcement Report
Ventolin HFA (albuterol sulfate) Inhalation Aerosol recalled
GlaxoSmithKline is recalling Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered, distributed in Mississippi, Vermont. The recall was initiated on 3 Dec 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0519-2016
- FDA event ID
- 72800
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Brand
- Ventolin
- Manufacturer
- GlaxoSmithKline LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2015
- FDA classified
- 9 Dec 2015
- Reported
- 16 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 3 Dec 2015 | Recall initiated by company | |
| 9 Dec 2015 | Classified by FDA | +6 days |
| 16 Dec 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Product as listed by the FDA
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
Where it was distributed
MS and VT
Questions about this recall
Why was it recalled?
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Which lots are affected?
Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Where was it sold?
MS and VT
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |