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.
11 recalls
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Class II Ongoing
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30×5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Reason: Labelling: Illegible label
Lots, distribution and details
- Lots / codes
- Lot AB6001, exp date 1/15/2027
- Distribution
- Nationwide within the United States
- Quantity
- 146,280 vials
- Recall started
- March 17, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0479-2026
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Class III Ongoing
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300…
Reason: Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Lots, distribution and details
- Product
- Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
- Lots / codes
- Lot#: 4IB0519, Exp. 04/30/2026
- Distribution
- U.S. Nationwide.
- Quantity
- 20352 packs (1x 200 MD)
- Recall started
- July 24, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0593-2025
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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 Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 – 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ…
Reason: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Lots, distribution and details
- Product
- Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 – 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
- Lots / codes
- Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
- Distribution
- USA nationwide.
- Quantity
- 59244/3ml FFS packs
- Recall started
- March 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0471-2024
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Class II Terminated
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 4…
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01
- Lots / codes
- Batch K100715
- Distribution
- Nationwide USA
- Quantity
- 11 cartons
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0163-2024
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Class II Terminated
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
- Lots / codes
- Batch MY7E
- Distribution
- Nationwide USA
- Quantity
- 2 cartons
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0162-2024
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Class II Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 – 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203;…
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 – 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
- Lots / codes
- Batch 21C56
- Distribution
- Nationwide USA
- Quantity
- 2 cartons
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0161-2024
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Class II Ongoing
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0856-2023
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Class II Ongoing
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0783-2023
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Class II Ongoing
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate
Lots, distribution and details
- Lots / codes
- Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
- Distribution
- Nationwide in the US and Puerto Rico
- Quantity
- 562,883
- Recall started
- May 16, 2017 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0793-2017
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Class II Ongoing
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Lots, distribution and details
- Product
- Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
- Lots / codes
- Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 593,088 inhalers
- Recall started
- March 22, 2017 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0626-2017
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.