CLASS II Drug recall · Reported 1 May 2024 · FDA Enforcement Report
Ipratropium Bromide and Albuterol Sulfate Inhalation recalled
Cipla USA is recalling Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg, distributed nationwide in the US. The recall was initiated on 26 Mar 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0471-2024
- FDA event ID
- 94289
- Recalling firm
- Cipla USA, Warren, NJ
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2024
- FDA classified
- 24 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Inhalers & Asthma Medication
Timeline
| 26 Mar 2024 | Recall initiated by company | |
| 24 Apr 2024 | Classified by FDA | +29 days |
| 1 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Which lots are affected?
Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cipla USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
Other Ipratropium recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg recalledIpratropium Bromide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate | Nephron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |