Recall Weekly
Moderate riskFDA DrugClass II

Sun Pharmaceutical budesonide suspension recalled for foreign particles

Sun Pharmaceutical has recalled budesonide inhalation suspension (1mg/2mL single-dose ampules) due to the presence of black or brown specs and particles found in some vials. The affected lot is BAG0074A with an expiration date of January 31, 2027. This is a quality issue that could affect the safety and sterility of the medication.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

  1. Check your budesonide ampules for lot number BAG0074A (expiration 1/31/2027)
  2. Do not use ampules from this lot if you see any discoloration, specs, or particles in the solution
  3. Contact your pharmacy or healthcare provider if you have this lot
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
N/A
Illnesses reported
None reported
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Classification
Class II
Recall number
D-0607-2026

In the FDA's words

Description
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. 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 Lot #: BAG0074A, Exp. Date: 1/31/2027. Distribution: Nationwide within the United States Affected quantity: N/A
Hazard
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

More from Sun Pharmaceutical

See all

Related topics

ParticulateDrugsSold nationwideMore from FDA Drug