Severity
Moderate
ModerateClass IITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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 FDA Drug action (record #D-0519-2016) was formally reported on December 16, 2015, with the manufacturer initiating the action on December 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. GlaxoSmithKline, LLC is listed as the recalling firm, operating out of Zebulon, NC. Federal records list the affected scope as 128,704 Inhalers.
The documented reason for this recall is: Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. Distribution data in the federal record shows the product reached: MS and VT. Distribution scope 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 - 3,056 household products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
128,704 Inhalers
Related Recalls
6
0 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by GlaxoSmithKline, LLC. Units affected: 128,704 Inhalers.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on December 16, 2015. Severity: Moderate. Recall number: D-0519-2016.
Where was the recalled product distributed? ▼
Distribution: MS and VT.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0519-2016) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 16, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.