Albuterol Sulfate Inhalation Solution — Class III drug recall D-1039-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-08-09, distributed nationwide. Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
| Recall number | D-1039-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-07-25 |
| Classified | 2017-07-31 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2018-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 401,750 cartons |
| Reason classes | specification failure |
| NDC | 00591-3467-53 |
| Lot numbers | 01/18, 06/18, 08/17, 09/17, 10/17, 11/17, 12/17, GA60206, GA60207, GA60283, GA60284, GA60378, GA60379, GA60478, GA60491, GA60615, GA60616, GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, GA70001, GA70031, GA70046, GA70047, GA70074, GA70075 |
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1039-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.