RecallRadar

FDA Drug recall D-0519-2016

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net…

On 2015-12-16 the FDA classified a Class II recall of Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net… by Glaxosmithkline, citing defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0519-2016
ClassificationClass II
Statusterminated
Initiated2015-12-03
Published2015-12-16
Last updated2026-09-13 11:51 UTC
CompanyGlaxosmithkline
DistributionMS, VT

Product

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

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

Identifiers

ndc0173-0682-20
ndc0173-0682-24
code_infoLot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.