Auvi-Q — Class I drug recall D-0872-2016
Terminated recall by Sanofi-Aventis U.S. LLC, reported 2016-06-01, distributed nationwide. Defective Delivery System; potential to have inaccurate dosage delivery
| Recall number | D-0872-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2016-05-25 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2025-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 383,900 prefilled |
| NDC | 00024-5833-00, 00025-5833-02 |
| Expiration dates | 2015-10, 2016-04, 2016-05, 2016-06, 2016-07, 2016-08, 2016-09, 2016-10, 2016-11, 2016-12 |
Product
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Reason for recall
Defective Delivery System; potential to have inaccurate dosage delivery
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-0872-2016. 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.