Budesonide Inhalation Suspension — Class II drug recall D-0607-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-06-17, distributed nationwide. Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint report
| Recall number | D-0607-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-05-29 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| NDC | 47335-0631, 47335-0631-48, 47335-0631-49, 47335-0632, 47335-0632-48, 47335-0632-49, 47335-0633, 47335-0633-48, 47335-0633-49 |
| Lot numbers | BAG0074A |
| Expiration dates | 2027-01-31 |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0607-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.