CLASS III Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Levalbuterol Inhalation Solution, USP, 0.31 mg/ Vials recalled by Cipla
Cipla is recalling Levalbuterol Inhalation Solution, USP, 0.31 mg/ Vials, distributed nationwide in the US. The recall was initiated on 24 Apr 2015 and the FDA has classified it as Class III.
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-1078-2015
- FDA event ID
- 71133
- Recalling firm
- Cipla, Pithampur, District Dhar, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Apr 2015
- FDA classified
- 14 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 24 Apr 2015 | Recall initiated by company | |
| 14 May 2015 | Classified by FDA | +20 days |
| 20 May 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Where it was distributed
U.S. Nationwide including Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Which lots are affected?
Lot #: FA4022; Expiry: December 2015.
Where was it sold?
U.S. Nationwide including Puerto Rico.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione | Cipla | Potency & Assay | Nationwide |
| Drug | CLASS II | Arformoterol Tartrate Inhalation Solution, 15 mcg/ Sterile Unit-Dose recalledArformoterol Tartrate | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLA | Cipla | Sterility | Nationwide |
Other Levalbuterol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levalbuterol Tartrate HFA Inhalation Aerosol recalledLevalbuterol Tartrate Hfa Inhalation | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Levalbuterol tartrate HFA Inhalation Aerosol recalled by Cardinal HealthLevalbuterol Tartrate Hfa Inhalation | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |