CLASS II ONGOING Drug recall · Reported 17 Jun 2026 · FDA Enforcement Report
Budesonide Inhalation Suspension, 1mg recalled
SUN Pharmaceutical Industries is recalling Budesonide Inhalation Suspension, 1mg/, mL Sterile Single-Dose Ampules (-Dose Ampules per, distributed nationwide in the US. The recall was initiated on 29 May 2026 and the FDA has classified it as Class II.
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-0607-2026
- FDA event ID
- 99113
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Budesonide
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2026
- FDA classified
- 18 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Inhalers & Asthma Medication
Timeline
| 29 May 2026 | Recall initiated by company | |
| 17 Jun 2026 | Published in enforcement report | +19 days |
| 18 Jun 2026 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Product as listed by the FDA
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Which lots are affected?
Lot #: BAG0074A, Exp. Date: 1/31/2027.
Where was it sold?
Nationwide within the United States
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.
More recalls from SUN Pharmaceutical Industries
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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Other Budesonide recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide | Cipla | Sterility | Nationwide |