Budesonide inhalation ampules contain black and brown specks and particles
Budesonide Inhalation Suspension, 1 mg/2 mL single-dose ampules from Sun Pharmaceutical, is being recalled after a quality complaint of black or brown specs and particles in the solution.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where visible particles were found in a product delivered to the airway, a risk of harm with no injuries reported in the source.
Plain-English summary
Budesonide Inhalation Suspension, 1 mg/2 mL, in 2 mL sterile single-dose ampules packed five ampules per pouch and six pouches per carton, distributed by Sun Pharmaceutical Industries, Inc. of Cranbury, New Jersey, is being recalled.
The stated reason is the presence of a foreign substance. The recall was initiated in response to a product quality complaint reported for black or brown specs and particles within the ampoule solution. The FDA classified the action as Class II.
The affected lot is BAG0074A, expiring 1/31/2027. Distribution was nationwide within the United States.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- BUDESONIDE (BUDESONIDE)
- Brand
- BUDESONIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Inhalation suspension
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: BAG0074A
- Exp. Date: 1/31/2027.
Distribution
Distributed nationwide across the United States.
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