In 2017, certain lots of EpiPen and EpiPen Jr Auto-Injectors were voluntarily recalled because a defective component could potentially prevent the device from activating during a severe allergic reaction. The recall affected 13 specific lots distributed between December 2015 and July 2016. Families were advised to keep their existing EpiPen available for emergency use until a replacement was obtained and to seek emergency medical attention after using epinephrine. This notice is historical; families should check current FDA information for active recalls.
The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Stericycle at 877-650-3494.
As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.
At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
| Product/Dosage | NDC Number | Lot Number | Expiration Date |
|---|---|---|---|
| EpiPen Jr Auto-Injector, 0.15 mg | 49502-501-02 | 5GN767 | April 2017 |
| EpiPen Jr Auto-Injector, 0.15 mg | 49502-501-02 | 5GN773 | April 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 5GM631 | April 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 5GM640 | May 2017 |
| EpiPen Jr Auto-Injector, 0.15 mg | 49502-501-02 | 6GN215 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM082 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM072 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM081 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM088 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM199 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM091 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM198 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM087 | October 2017 |
The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or
- Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Frequently Asked Questions
Why were EpiPens recalled in 2017?
Certain EpiPen and EpiPen Jr Auto-Injectors were voluntarily recalled because they could contain a defective component that might prevent the device from activating. This could be dangerous during a severe allergic reaction when epinephrine is urgently needed.
Which EpiPens were included in the recall?
The 2017 U.S. recall involved 13 specific lots of EpiPen and EpiPen Jr Auto-Injectors. These products were distributed between December 17, 2015 and July 1, 2016. EpiPens from other lots were not included in that particular recall.
Were both EpiPen and EpiPen Jr recalled?
Yes. The affected lots included both the 0.3 mg EpiPen Auto-Injector and the 0.15 mg EpiPen Jr Auto-Injector.
What was wrong with the recalled EpiPens?
The affected devices could contain a defective component that might cause the auto-injector to fail to activate. Although the number of reported failures was small, the products were recalled because failure during a severe allergic reaction could create a life-threatening situation.
What were families told to do with a recalled EpiPen?
At the time of the recall, consumers were advised to keep their current EpiPen available for emergency use until they received a replacement rather than being left without epinephrine.
