Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
6 recalls
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Class II Ongoing
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, Manufactur…
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
Lots, distribution and 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.
- Lots / codes
- Lot #: BAG0074A, Exp. Date: 1/31/2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- May 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0607-2026
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Class II Ongoing
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 Bouleva…
Reason: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Lots, distribution and details
- 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)
- Lots / codes
- Batch # 4IA0505, Exp 09/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 13,680 ampoules
- Recall started
- June 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0541-2025
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Class II Ongoing
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: Ast…
Reason: Defective delivery system
Lots, distribution and details
- Product
- Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
- Lots / codes
- Lot#: a) 6270044C00, 6270040D00, 6270034E00, Exp Date 10/2026; 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00 Exp 11/30/2026; 6270064C00, 6270071D00, 6270075D00, 6270075F00 Exp Date 12/31/2026; 6270107C00, Exp Date 9/30/2027; b) Lot 6270019E00, Exp Date 7/31/2025; 6270021D00, Exp 8/31/2025; 6270095C00, Exp 2/28/2026
- Distribution
- USA Nationwide
- Quantity
- a) 807,837 canisters; b) 235,698 canisters
- Recall started
- May 14, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0444-2025
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Class II Completed
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Reason: CGMP Deviations and Presence of Particulate Matter: Glass
Lots, distribution and details
- Lots / codes
- Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
- Distribution
- Nationwide in the USA and Canada
- Quantity
- 113 bottles
- Recall started
- June 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0570-2024
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Class II Terminated
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot #: GS054862, Exp. Date 07/31/2025
- Distribution
- Illinois only
- Quantity
- 108 bottles
- Recall started
- January 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0276-2024
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Class II Ongoing
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 0591-2…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- 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
- Lots / codes
- Lot # 100047273; Exp. 07/2025
- Distribution
- Nationwide
- Quantity
- 10,672 30-count bottles
- Recall started
- January 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0275-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.