FDA Drug recall D-0607-2026
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Di…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Di… by Sun Pharmaceutical Industries, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0607-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-29 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
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
Identifiers
| ndc | 47335-631-48 |
|---|---|
| ndc | 47335-631-49 |
| ndc | 47335-632-48 |
| ndc | 47335-632-49 |
| ndc | 47335-633-48 |
| ndc | 47335-633-49 |
| code_info | Lot #: BAG0074A, Exp. Date: 1/31/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0607-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.