CLASS III Drug recall · Reported 3 Jun 2015 · FDA Enforcement Report
QVAR (beclomethasone dipropionate HFA 40 mcg) recalled
Teva Pharmaceuticals USA is recalling QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral, distributed nationwide in the US. The recall was initiated on 7 May 2015 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-1087-2015
- FDA event ID
- 71140
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 May 2015
- FDA classified
- 28 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 May 2015 | Recall initiated by company | |
| 28 May 2015 | Classified by FDA | +21 days |
| 3 Jun 2015 | 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 Impurities/Degradation Specifications: out of specification test results for an impurity 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
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
Where it was distributed
Nationwide and Peurto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Which lots are affected?
Lot #s:130449, 130450; Exp. Date: 12/2015
Where was it sold?
Nationwide and Peurto 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 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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Other Qvar (beclomethasone Dipropionate Hfa recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | QVAR¿ (beclomethasone dipropionate HFA) recalled | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |