Stop using now Drug recall · FDA · Published October 28, 2015

Auvi-Q Epinephrine Recall: Defective Delivery System

Sanofi-Aventis recalls Auvi-Q auto-injectors due to a defective delivery system that may cause inaccurate dosage. Check your lot numbers immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0872-2016Drug Auvi-Q ›

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Defective Delivery System; potential to have inaccurate dosage delivery

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Contact the company

Recalling firmSanofi-Aventis U.S. LLC55 Corporate Dr · Bridgewater, NJ 08807-1265

✎ GovInfoNow plain-language explainer

Sanofi-Aventis U.S. LLC is recalling specific lots of Auvi-Q (epinephrine injection, USP) Auto-Injectors because the delivery system is defective and may deliver an inaccurate dose. This affects both the 2-prefilled auto injector + 1 trainer kits (NDC 0025-5833-02) and the 1-prefilled auto injector + 1 trainer kits (NDC 0024-5833-00). The recall covers approximately 383,900 units distributed nationwide. The record does not specify the remedy or return process for these items. Read more at govinfonow.com/recall/43414-sanofi-aventis-u-s-llc-recalls-auvi-q-epinephrine-injection.

Source Summary by GovInfoNow · govinfonow.com/recall/43414-sanofi-aventis-u-s-llc-recalls-auvi-q-epinephrine-injection · Updated October 11, 2026 · FDA enforcement record: FDA #D-0872-2016

Cite this page

“Auvi-Q Epinephrine Recall: Defective Delivery System.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43414-sanofi-aventis-u-s-llc-recalls-auvi-q-epinephrine-injection. Based on FDA recall #D-0872-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0872-2016%22&limit=1).

The FDA announced on Oct. 28, 2015, that Sanofi-Aventis U.S. LLC voluntarily recalled Auvi-Q epinephrine auto-injectors due to a defective delivery system that may result in inaccurate dosage. The agency issued recall number D-0872-2016 for the Class I product.

How to tell if you have it

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg
NDC 0025-5833-02: 2 prefilled auto injectors + 1 trainer
NDC 0024-5833-00: 1 prefilled auto injector + 1 trainer
Lot codes: 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); 2299596 (exp 03/2016)
Nationwide distribution

The hazard

The recall addresses a defective delivery system in the Auvi-Q auto-injectors that poses a potential for inaccurate dosage delivery. The FDA classified this as a Class I recall, indicating the highest degree of hazard.

Context

GovInfoNow's records show Sanofi-Aventis U.S. LLC has had 9 other recalls on record since 2016-09-01. Other recent recalls of similar products include Fresenius Kabi Epinephrine Injection Recall (2026-05-14), EPINEPHR Sterility Risk in 1 mg/10mL Injection Recall (2026-04-01), and ANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers (2026-05-12).

How to tell if you have this one

Check your Auvi-Q device for the following National Drug Codes (NDC): 0025-5833-02 or 0024-5833-00. If you have these NDCs, verify the lot number and expiration date against the list: Lot 2081278 (exp 10/2015), 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), and Lot 2299596 (exp 03/2016).

Brand
Auvi-Q
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
D-0872-2016	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; 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	383,900 prefilled syringes
D-0873-2016	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; 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	159,000 prefilled injectors

Based on the official FDA remedy

What to do — step by step

Check Your Device
Verify if your Auvi-Q device matches the NDCs 0025-5833-02 or 0024-5833-00 and check the lot number against the recalled list.
Contact Your Pharmacist
Reach out to your pharmacy or healthcare provider to discuss how to replace the recalled device, as the specific remedy is not detailed in this record.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9.7 years after the firm started it.

Oct 28, 2015Firm started the recall
May 25, 2016FDA classified it Class I
Jun 1, 2016Published in FDA’s Enforcement Report
Jul 15, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/43414-sanofi-aventis-u-s-llc-recalls-auvi-q-epinephrine-injection">Auvi-Q Epinephrine Recall: Defective Delivery System (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0872-2016 (October 28, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0872-2016 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.