Ventolin HFA — Class II drug recall D-0626-2017
Ongoing recall by GlaxoSmithKline, LLC, reported 2017-04-12, distributed nationwide. Defective Delivery System: Elevated number of units with out of specification results for leak rate.
| Recall number | D-0626-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline, LLC, Zebulon, NC, United States |
| Recall initiated | 2017-03-22 |
| Classified | 2017-03-31 |
| Reported by FDA | 2017-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 593,088 inhalers |
| Reason classes | specification failure, packaging |
| NDC | 00173-0682, 00173-0682-20, 00173-0682-24 |
| Lot numbers | 03/18, 04/18, 6ZP0003, 6ZP9848, 6ZP9944 |
Product
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Reason for recall
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
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-0626-2017. 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.