Ventolin HFA — Class II drug recall D-1666-2012
Terminated recall by GlaxoSmithKline Inc, reported 2012-09-05, distributed nationwide. Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
| Recall number | D-1666-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline Inc, Zebulon, NC, United States |
| Recall initiated | 2012-07-26 |
| Classified | 2012-08-28 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2014-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,412,566 inhalers |
| NDC | 00173-0682, 00173-0682-20, 00173-0682-24 |
| Lot numbers | 01/13, 03/13, 04/13, 1ZP0414, 1ZP0464, 1ZP0570, 1ZP0576, 1ZP0919, 1ZP7355, 1ZP7729, 1ZP7749, 1ZP8141, 1ZP8147, 2ZP4959, 2ZP4966 |
Product
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
Reason for recall
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
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-1666-2012. 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.