Albuterol Sulfate: 11 recalls on record

Recalled by 1 agency: FDA (11).

First recall on record: August 15, 2012. Most recent: August 27, 2025.

Risk classification: Class I: 1 · Class II: 9 · Class III: 1

Most recent recalls

DateAgencyProduct
August 27, 2025FDAAlbuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g…D-0593-2025
January 3, 2024FDAALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, N…D-0162-2024
January 3, 2024FDAALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Con…D-0163-2024
July 19, 2023FDAAlbuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g c…D-0938-2023
June 15, 2022FDAAlbuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalat…D-1024-2022
June 15, 2022FDAAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose …D-1020-2022
June 15, 2022FDAAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose …D-1019-2022
June 15, 2022FDAAlbuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile…D-1018-2022
September 30, 2020FDAAlbuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manu…D-1594-2020
October 30, 2013FDAAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx O…D-66462-001
August 15, 2012FDAAlbuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-co…D-1446-2012

Questions about this brand

How many recalls does Albuterol Sulfate have?
Recalert has 11 U.S. recalls on record for Albuterol Sulfate, published between August 15, 2012 and August 27, 2025.
What was the most recent Albuterol Sulfate recall?
FDA recall D-0593-2025, published August 27, 2025: 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…
Which agencies have recalled Albuterol Sulfate products?
Albuterol Sulfate products appear in recalls from: FDA (11).

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