CLASS III Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Albuterol Sulfate Inhalation Solution, 021% 63 mg recalled
Teva Pharmaceuticals U is recalling Albuterol Sulfate Inhalation Solution, 021% 63 mg, distributed nationwide in the US. The recall was initiated on 25 Jul 2017 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-1039-2017
- FDA event ID
- 77832
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Jul 2017
- FDA classified
- 31 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Inhalers & Asthma Medication
Timeline
| 25 Jul 2017 | Recall initiated by company | |
| 31 Jul 2017 | Classified by FDA | +6 days |
| 9 Aug 2017 | Published in enforcement report | +9 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: high out of specification results for related compound D.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Albuterol Sulfate Inhalation Solution, 021% 63 mg recalled?
Yes. Teva Pharmaceuticals U recalled Albuterol Sulfate Inhalation Solution, 021% 63 mg on 25 Jul 2017. The recall is Class III and its status is Terminated. Recall number D-1039-2017.
Why was it recalled?
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Which lots are affected?
Lot #s: GA60206, GA60207, Exp 08/17; GA60283, GA60284, Exp 09/17; GA60378, GA60379, GA60478, Exp 10/17; GA60491, Exp 11/17; GA60615, GA60616, Exp 12/17; GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, Exp 01/18; GA70001, GA70031, GA70046, GA70047, GA70074, GA70075, Exp 06/18
Where was it sold?
Nationwide in the USA and 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Albuterol sulfate inhalation recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 5%, 25 mg recalled by Nephron SC | Nephron SC | Sterility | Nationwide |
| Drug | CLASS III | Albuterol Sulfate Inhalation Solution, USP, 021% 63 mg / Vials recalled | Actavis | Potency & Assay | Nationwide |