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Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Recall 2026

BUDESONIDEIssued May 29, 2026Updated Reviewed by the Recall Watch editorial team

BUDESONIDE 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, — recalled per FDA on 5/29/2026. Reason: 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.

Agency
FDA
Issued
May 29, 2026
Brand
BUDESONIDE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued May 29, 2026 · Last synced Nov 1, 2026

What's recalled

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.

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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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: BAG0074A
Exp. Date: 1/31/2027.
Where was it sold
1 state

Nationwide within the United States

nationwide
Official noticefda.gov
More recalls like this
5 related — by brand, contaminant, and category

Frequently asked questions

Is the BUDESONIDE recall still active?

Yes, this recall is currently active as of May 29, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: BAG0074A, Exp. Date: 1/31/2027.. Check the label on your product.

What should I do if I have the recalled BUDESONIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.