CLASS II Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg recalled

GlaxoSmithKline is recalling Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered, distributed nationwide in the US. The recall was initiated on 26 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13

NDC0173-0682

Quantity recalled1,412,566 inhalers

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1666-2012
FDA event ID: 62799
Recalling firm: GlaxoSmithKline, Zebulon, NC
Brand: Ventolin
Manufacturer: GlaxoSmithKline LLC
Classification: Class II
Status: Terminated
Recall initiated: 26 Jul 2012
FDA classified: 28 Aug 2012
Reported: 5 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Inhalers & Asthma Medication

Timeline

26 Jul 2012	Recall initiated by company
28 Aug 2012	Classified by FDA	+33 days
5 Sep 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Product as listed by the FDA

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Which lots are affected?

Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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