Budesonide recalls: 6 FDA reports
Recalls involving Budesonide. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
3Ongoing
2026-06-17Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per po
D-0607-2026 · Class II · reported 2026-06-17 · Ongoing
- 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
- 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.
- Where it went
- Nationwide within the United States
- How much
- N/A
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manuf
D-0541-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- Product
- Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
- Where it went
- Distributed Nationwide in the USA
- How much
- 13,680 ampoules
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,
D-0275-2024 · Class II · reported 2024-02-07 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
- Where it went
- Nationwide
- How much
- 10,672 30-count bottles
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose
D-1545-2022 · Class II · reported 2022-10-05 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 641,160 ampules
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
D-199-2013 · Class III · reported 2013-03-20 · Terminated
- Why it was recalled
- Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
- Product
- PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
- Where it went
- Nationwide
- How much
- 64675 cartons
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
D-198-2013 · Class III · reported 2013-03-20 · Terminated
- Why it was recalled
- Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
- Product
- PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
- Where it went
- Nationwide
- How much
- 28,476 cartons
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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