CLASS III Drug recall · Reported 14 Dec 2016 · FDA Enforcement Report
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg recalled
Teva Pharmaceuticals U is recalling Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, distributed nationwide in the US. The recall was initiated on 1 Nov 2016 and the FDA has classified it as Class III.
Check your package
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-0170-2017
- FDA event ID
- 75565
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Nov 2016
- FDA classified
- 8 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 1 Nov 2016 | Recall initiated by company | |
| 8 Dec 2016 | Classified by FDA | +37 days |
| 14 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).
Where it was distributed
Nationwide
Questions about this recall
Is Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays recalled?
Yes. Teva Pharmaceuticals U recalled Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays on 1 Nov 2016. The recall is Class III and its status is Terminated. Recall number D-0170-2017.
Why was it recalled?
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Which lots are affected?
Lot #: 150096, Exp. 3/2017; Lot #: 150327, Exp. 10/2017
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 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.
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