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
Sun Pharmaceutical Industries Inc. is recalling Budesonide Inhalation Suspension, 1mg/2mL, because the solution may contain black or brown foreign particles. The recall covers units distributed nationwide with NDC 47335-633-49 and Lot # BAG0074A, expiring on 1/31/2027. No remedy has been announced yet. Read more at govinfonow.com/recall/31249-sun-pharma-recalls-budesonide-inhalation-suspension-due-to-foreign-particles.
“Sun Pharma Recalls Budesonide Inhalation Suspension Due to Foreign Particles.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31249-sun-pharma-recalls-budesonide-inhalation-suspension-due-to-foreign-particles. Based on FDA recall #D-0607-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0607-2026%22&limit=1).
Sun Pharmaceutical Industries Inc. recalled Budesonide Inhalation Suspension on May 29, 2026, due to black or brown specs and particles in the solution, according to the FDA. The agency announced the Class II recall of lot BAG0074A.
How to tell if you have it
Brand: Sun Pharmaceutical Industries
Product: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules
NDC: 47335-633-49
Lot #: BAG0074A
Exp. Date: 1/31/2027
The hazard
The recall addresses a product quality complaint regarding the presence of black or brown specs and particles within the ampoule solution.
Context
GovInfoNow's records show Sun Pharmaceutical Industries Inc. has 93 other recalls on record since May 21, 2013. Other recent recalls include a Nystatin Cream recall for failed stability specifications on Sept. 14, 2026, and a Carbamazepine Tablets recall for black spots from burnt ingredients on Aug. 3, 2026. Other recent recalls of similar products include a Vitamin B-Complex Liquid recall due to foreign particles on May 1, 2026, a Children's Ibuprofen recall due to a foreign substance on March 2, 2026, and an ACETYLCYSTEINE Solution recall for particulate matter hazard on July 24, 2026.
How to tell if you have this one
Check your medication box for NDC 47335-633-49 and Lot # BAG0074A with an expiration date of 1/31/2027. The product is Budesonide Inhalation Suspension, 1mg/2mL, sold in 30 x 2 mL sterile single-dose ampules (5 per pouch, 6 pouches per carton). Look for black or brown particles inside the solution.
Brand
Sun Pharmaceutical Industries
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify if your Budesonide Inhalation Suspension matches NDC 47335-633-49 and Lot # BAG0074A with an expiration date of 1/31/2027.
Inspect For Particles
Look inside the ampoule solution for any black or brown specs or particles before use.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist to determine if you have the recalled product and what steps to take next, as no official remedy is currently stated.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0607-2026 (May 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0607-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.