Budesonide Inhalation Suspension recall
FDA recall D-0607-2026 · initiated May 29, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Budesonide Inhalation Suspension in May 2026 — an FDA Class II recall (D-0607-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 29, 2026
- FDA report date
- Jun 17, 2026
Frequently asked
- Was Budesonide Inhalation Suspension recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Budesonide Inhalation Suspension in May 2026 — an FDA Class II recall (D-0607-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Budesonide Inhalation Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0607-2026 was: 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
- Is a recalled Budesonide Inhalation Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Budesonide Inhalation Suspension are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: BAG0074A, Exp. Date: 1/31/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0607-2026.