CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg recalled

Sanofi-Aventis U.S is recalling Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors, distributed nationwide in the US. The recall was initiated on 28 Oct 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) 2081278, 2113841, 2113842, 2144138, exp 10/2015; 2440675, exp 04/2016; 2506456, 2506460, 2546946, 2546947, exp 05/2016; 2620206, 2620207, 2659534, exp 06/2016; 2692111, 2692112, exp 07/2016; 2716517, 2719817, 2734079, 2734080, 2734081, 2778035, 2800128, exp 08/2016; 2800130, 2824828, 2824829, 2857516, 2867928, 2870928, 2867929, 2867930, 2883616, 2883617, exp 09/2016; 2883618, 2883619, 2974267, 2883620, 2945419, 2974269, exp 10/2016; 3026968, 3026969, exp 11/2016; 3026970, 3028227, 3032005, 3037217, 3037218, 3037219, exp 12/2016; b) 2299596, 03/2016

Quantity recalled383,900 prefilled syringes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0872-2016
FDA event ID: 72527
Recalling firm: Sanofi-Aventis U.S, Bridgewater, NJ
Classification: Class I
Status: Terminated
Recall initiated: 28 Oct 2015
FDA classified: 25 May 2016
Reported: 1 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Labeling Errors
Drug class: Allergy Medication

Timeline

28 Oct 2015	Recall initiated by company
25 May 2016	Classified by FDA	+210 days
1 Jun 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Defective Delivery System; potential to have inaccurate dosage delivery

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Defective Delivery System; potential to have inaccurate dosage delivery

Which lots are affected?

a) 2081278, 2113841, 2113842, 2144138, exp 10/2015; 2440675, exp 04/2016; 2506456, 2506460, 2546946, 2546947, exp 05/2016; 2620206, 2620207, 2659534, exp 06/2016; 2692111, 2692112, exp 07/2016; 2716517, 2719817, 2734079, 2734080, 2734081, 2778035, 2800128, exp 08/2016; 2800130, 2824828, 2824829, 2857516, 2867928, 2870928, 2867929, 2867930, 2883616, 2883617, exp 09/2016; 2883618, 2883619, 2974267, 2883620, 2945419, 2974269, exp 10/2016; 3026968, 3026969, exp 11/2016; 3026970, 3028227, 3032005, 3037217, 3037218, 3037219, exp 12/2016; b) 2299596, 03/2016

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72527

Reported	Class	Recall	Company	Reason	Where
1 Jun 2016	CLASS I	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg recalled	Sanofi-Aventis U.S	Labeling Errors	Nationwide

More recalls from Sanofi-Aventis U.S

All 22

Reported	Class	Recall	Company	Reason	Where
24 May 2023Drug	CLASS II	Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog	Sanofi-Aventis U.S	Sterility	Nationwide
26 Aug 2020Drug	CLASS II	Elitek (rasburicase) for injection, 7.5 mg vial recalledElitek	Sanofi-Aventis U.S	Potency & Assay	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Zantac 75 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide
11 Dec 2019Drug	CLASS II	Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S	Sanofi-Aventis U.S	Nitrosamine Impurity	Nationwide

Other Auvi-q (epinephrine recalls

All 2

Reported	Class	Recall	Company	Reason	Where
1 Jun 2016Drug	CLASS I	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg recalled	Sanofi-Aventis U.S	Labeling Errors	Nationwide