Ventolin HFA Inhalers Recalled for Insufficient Propellant Delivery
GlaxoSmithKline is recalling Ventolin HFA inhalers because some may not deliver the full 200 actuations labeled on the canister.
What this means for you
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. The hazard is a functional defect (insufficient propellant) rather than a toxicological or contamination risk, and no injuries or illnesses are reported in the source text.
Plain-English summary
GlaxoSmithKline, LLC is recalling 128,704 units of Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation. The recall affects specific lots distributed in Mississippi and Vermont. The identified lots are 5ZP1708 (Exp. 12/2016) and 5ZP1951 (Exp. 02/2017).
The recall was initiated due to a defective delivery system. Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of the shelf life. This means the medication may run out before the expiration date or the actuation count indicated on the label.
Patients using these specific inhalers should contact their healthcare provider or pharmacist for a replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- VENTOLIN (ALBUTEROL SULFATE)
- Brand
- VENTOLIN
- Manufacturer
- GlaxoSmithKline, LLC
- Category
- Drug — Inhalation Aerosol
- Affected units
- 128,704
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 (4)
- Lot #s: 5ZP1708
- Exp. 12/2016
- 5ZP1951
- Exp. 02/2017
Distribution
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- HighGlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-05-31
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FDA (Drugs) · 2017-04-12
- HighGlaxoSmithKline Recalls Ventolin Inhalers Due to Low Albuterol Content
FDA (Drugs) · 2012-09-05
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