Auvi-Q Epinephrine (Sanofi) – Dosage Delivery Issue (2015)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Brand
Sanofi-Aventis U.S. LLC
Lot Codes / Batch Numbers
a) 2144144, exp 10/2015, 2469674, exp 04/2016, 2506492, 2546978, 2546979, exp 05/2016, 2654817, 2654818, exp 06/2016, 2692143, 2692144, exp 07/2016, 2719838, exp 08/2016, 2824845, 2891021, 2857530, exp 09/2016, 2883631, 2883632, exp 10/2016, 2883633, 2945429, 3028243, exp 11/2016, 3037230, 2966680, 2974276, 2974280, exp 12/2016, and b) 2525474, exp 05/2016
Products Sold
a) 2144144, exp 10/2015; 2469674, exp 04/2016; 2506492, 2546978, 2546979, exp 05/2016; 2654817, 2654818, exp 06/2016; 2692143, 2692144, exp 07/2016; 2719838, exp 08/2016; 2824845, 2891021, 2857530, exp 09/2016; 2883631, 2883632, exp 10/2016; 2883633, 2945429, 3028243, exp 11/2016; 3037230, 2966680, 2974276, 2974280, exp 12/2016; and b) 2525474, exp 05/2016
Sanofi-Aventis U.S. LLC is recalling Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 traine due to Defective Delivery System; potential to have inaccurate dosage delivery. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Delivery System; potential to have inaccurate dosage delivery
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026