CLASS III Drug recall · Reported 20 Mar 2013 · FDA Enforcement Report
Pulmicort Respules 0.25 mg/ Budesonide Inhalation recalled
AstraZeneca is recalling Pulmicort Respules 0.25 mg/ Budesonide Inhalation Suspension (30 ampules/carton), distributed nationwide in the US. The recall was initiated on 11 Jan 2013 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-198-2013
- FDA event ID
- 64041
- Recalling firm
- AstraZeneca, Westborough, MA
- Brand
- Pulmicort Respules
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Jan 2013
- FDA classified
- 12 Mar 2013
- Reported
- 20 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 11 Jan 2013 | Recall initiated by company | |
| 12 Mar 2013 | Classified by FDA | +60 days |
| 20 Mar 2013 | 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 Meet Monograph: Budesonide may be slightly above or below the specification range.
Product as listed by the FDA
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Which lots are affected?
Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
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 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.
Other products in this recall event
1 other product · FDA event 64041This product is part of a recall event; the main page for the event is Pulmicort Respules 0.5 mg/ (30 ampules/carton) Budesonide recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Pulmicort Respules 0.5 mg/ (30 ampules/carton) Budesonide recalledPulmicort Respules | AstraZeneca | Other | Nationwide |
More recalls from AstraZeneca
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pulmicort Respules 0.5 mg/ (30 ampules/carton) Budesonide recalledPulmicort Respules | AstraZeneca | Other | Nationwide |
Other Budesonide recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide | Cipla USA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide, USP (Micronized), 500 mg recalled by Medisca | Medisca | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets 9mg recalledBudesonide | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets, 9 mg recalled | Golden State Medical Supply | Potency & Assay | IL |