Albuterol Sulfate Inhalation Solution — Class III drug recall D-0439-2017
Terminated recall by Actavis Inc, reported 2017-02-01, distributed nationwide. Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
| Recall number | D-0439-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2017-01-12 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 164,844 units |
| Reason classes | specification failure |
| NDC | 00591-3467-53 |
| Lot numbers | FEB-2017, GA51265, GA51454, GA51553, GA51583, GA51598, GA51724, GA51725, GA51749, JAN-2017, MAR-2017 |
Product
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Reason for recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
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-0439-2017. 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.