Sun Pharmaceutical is recalling Budesonide Inhalation Suspension due to black/brown particles found in some ampules. This may cause irritation or injury if inhaled. Consumers should check their product and contact the company for details.
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 is recalling Budesonide Inhalation Suspension 1mg/2mL ampules because they contain black or brown particles. This could cause irritation or injury if inhaled, so affected users should stop using the product and contact the company.
The product contains black or brown particles that can be inhaled. Inhaling these particles may cause irritation or injury to the respiratory system. This is a quality issue, not a safety hazard in normal use.
People using Budesonide Inhalation Suspension 1mg/2mL ampules from Sun Pharmaceutical. Those with respiratory conditions may be at higher risk if particles are inhaled.
Check for black or brown particles in the ampule solution. The product is labeled as Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 per pouch, 6 pouches per carton).
Inspect the ampule solution for black or brown particles before use.
Reach out to Sun Pharmaceutical for further instructions or to return the product.
The product may contain black or brown particles, which could cause irritation if inhaled. Do not use if particles are visible.
Check for black or brown particles in the ampule solution. The product is Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 per pouch, 6 pouches per carton).
Inspect the product for particles. If particles are present, stop using it and contact Sun Pharmaceutical for instructions.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0607-2026 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0607-2026 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
