GlaxoSmithKline Recalls Ventolin Inhalers Due to Defective Delivery System
GlaxoSmithKline is recalling 593,088 Ventolin inhalers because some units have out-of-specification leak rates, potentially affecting drug delivery.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a quality issue (leak rate) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GlaxoSmithKline, LLC is recalling 593,088 units of Ventolin (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations. The recall involves specific lots: 6ZP9848 (Exp 03/18), 6ZP0003, and 6ZP9944 (Exp 04/18). The product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to a defective delivery system, specifically an elevated number of units with out-of-specification results for leak rate. This defect may affect the performance of the inhaler.
Consumers with these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment options.
The recalled product
- Product
- VENTOLIN (ALBUTEROL SULFATE)
- Brand
- VENTOLIN
- Manufacturer
- GlaxoSmithKline, LLC
- Category
- Drug — Inhalation Aerosol
- Affected units
- 593,088
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: 6ZP9848
- Exp 03/18
- 6ZP0003
- 6ZP9944
- Exp 04/18.
Distribution
Related recalls
Same brand · VENTOLIN
- HighGlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-05-31
- ModerateVentolin HFA Inhalers Recalled for Insufficient Propellant Delivery
FDA (Drugs) · 2015-12-16
- HighGlaxoSmithKline Recalls Ventolin Inhalers Due to Low Albuterol Content
FDA (Drugs) · 2012-09-05
Same manufacturer · GlaxoSmithKline, LLC
See all →- ModerateTIVICAY HIV medication carton mislabeled with incorrect expiration date
FDA (Drugs) · 2024-06-12
- ModerateAnoro Ellipta inhalation powder recalled for failed release testing defect
FDA (Drugs) · 2024-01-03
- ModerateDrug Recall: Tivicay Tablets with Incorrect Expiration Date on Label
FDA (Drugs) · 2022-06-01
- SevereGlaxoSmithKline Recalls Bactroban Nasal Ointment Due to Penicillin Contamination
FDA (Drugs) · 2016-07-27
- SevereGlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination
FDA (Drugs) · 2016-07-27
Same hazard · defective delivery system
See all →- HighAmneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
FDA (Drugs) · 2026-09-30
- ModerateCetrorelix injection kits recalled over missing or duplicated needles inside
FDA (Drugs) · 2026-02-18
- HighAIRSUPRA Albuterol and Budesonide Inhalation Aerosol Recalled for Defective Delivery System
FDA (Drugs) · 2025-05-28
- HighLorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage
FDA (Drugs) · 2025-03-12
- ModerateVarithena Administration Pack Recalled Due to Incorrect Syringe Connector Type
FDA (Drugs) · 2024-12-18
Similar recalls
- HighGlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-05-31
- HighGlaxoSmithKline Recalls Ventolin Inhalers Due to Low Albuterol Content
FDA (Drugs) · 2012-09-05
- ModerateVentolin HFA Inhalers Recalled for Insufficient Propellant Delivery
FDA (Drugs) · 2015-12-16
- HighPerrigo Recalls Albuterol Sulfate Inhalers Due to Defective Delivery System
FDA (Drugs) · 2020-09-30
- LowGlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues
FDA (Drugs) · 2012-12-05
- CriticalPrescription albuterol inhalers recalled nationwide due to defective valve seals
FDA (Drugs) · 2023-07-19