FDA Drug recall · Reported December 16, 2015
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
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
GlaxoSmithKline, LLC recalled Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered I… - a moderate-severity action.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered I… was recalled by GlaxoSmithKline, LLC in December 16, 2015. Reason: Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim …. Check the official notice for the remedy. Verify recall #D-0519-2016 with the FDA Drug before acting.
The recall
GlaxoSmithKline, LLC issued this moderate-severity FDA Drug recall-Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim ….
- Moderate
- severity level
- Class II
- classification
- December 16, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0519-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Household Products recalls over time
Where this recall sits in its category - 3,089 household products recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0519-2016 |
| Date reported | December 16, 2015 |
| Date initiated | December 3, 2015 |
| Recalling firm | GlaxoSmithKline, LLC |
| Firm location | Zebulon, NC |
| Affected scope | 128,704 Inhalers |
| Distribution | MS and VT |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0519-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Household Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with CCM Hockey U.S. Recalls FMHVR Hybrid Visors and ACCHVR Repl… → · All Household Products recalls
Methodology · Corrections · Archive as of August 2026