CLASS II ONGOING Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Ventolin HFA (albuterol sulfate) Inhalation recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, distributed nationwide in the US. The recall was initiated on 16 May 2017 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-0793-2017
- FDA event ID
- 77329
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Brand
- Ventolin
- Manufacturer
- GlaxoSmithKline LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 May 2017
- FDA classified
- 22 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 16 May 2017 | Recall initiated by company | |
| 22 May 2017 | Classified by FDA | +6 days |
| 31 May 2017 | Published in enforcement report | +9 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: Elevated number of units with out of specification results for leak rate
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US and Puerto Rico
Questions about this recall
Why was it recalled?
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Which lots are affected?
Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
Where was it sold?
Nationwide in the US and Puerto Rico
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.
More recalls from GlaxoSmithKline
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|---|---|---|---|---|---|
| Drug | CLASS III | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recalled | GlaxoSmithKline | Other | Nationwide |
| Drug | CLASS III | Anoro Ellipta (umeclidinium recalled by GlaxoSmithKlineAnoro Ellipta | GlaxoSmithKline | Potency & Assay | Nationwide |
| Drug | CLASS III | Tivicay (dolutegravir) Tablets 50 mg recalled by GlaxoSmithKline | GlaxoSmithKline | Other | Nationwide |
| Drug | CLASS II | Ventolin HFA (albuterol sulfate) Inhalation Aerosol recalledVentolin | GlaxoSmithKline | Potency & Assay | Nationwide |
| Drug | CLASS II | Bactroban Cream, (Mupirocin Calcium Cream 2%) tube recalled | GlaxoSmithKline | Other | Nationwide |
Other Albuterol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | Nationwide |
| Drug | CLASS III | Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra | AsttraZeneca Pharmaceuticals | Packaging Defects | Nationwide |
| 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 |