CLASS III Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report

Qnasl (beclomethasone dipropionate) Nasal Aerosol recalled

Teva Pharmaceuticals U is recalling Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, distributed nationwide in the US. The recall was initiated on 4 Dec 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14
Quantity recalled379,463 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-382-2014
FDA event ID
67010
Recalling firm
Teva Pharmaceuticals U, Horsham, PA
Classification
Class III
Status
Terminated
Recall initiated
4 Dec 2013
FDA classified
20 Dec 2013
Reported
1 Jan 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons
Drug class
Nasal Sprays

Timeline

4 Dec 2013Recall initiated by company
20 Dec 2013Classified by FDA+16 days
1 Jan 2014Published in enforcement report+12 days

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

Reason for recall

Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.

Product as listed by the FDA

Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays recalled?

Yes. Teva Pharmaceuticals U recalled Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays on 4 Dec 2013. The recall is Class III and its status is Terminated. Recall number D-382-2014.

Why was it recalled?

Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.

Which lots are affected?

Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14

Where was it sold?

Nationwide and Puerto Rico

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Teva Pharmaceuticals U

All 196