CLASS I ONGOING Drug recall · Reported 10 May 2017 · FDA Enforcement Report
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg recalled
Meridian Medical Technologies a Pfizer is recalling EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, distributed nationwide in the US. The recall was initiated on 12 Mar 2017 and the FDA has classified it as Class I.
Check your package
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-0690-2017
- FDA event ID
- 76789
- Recalling firm
- Meridian Medical Technologies a Pfizer, Brentwood, MO
- Brand
- Epipen
- Manufacturer
- Viatris Specialty LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Mar 2017
- FDA classified
- 28 Apr 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 12 Mar 2017 | Recall initiated by company | |
| 28 Apr 2017 | Classified by FDA | +47 days |
| 10 May 2017 | Published in enforcement report | +12 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; reports of the device failing to activate which could result in a patient not receiving medication
Product as listed by the FDA
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
Where it was distributed
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
Questions about this recall
Why was it recalled?
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Which lots are affected?
US: lot 5GM631, exp. April 2017; lot 5GM640, exp. May 2017; lot 6GM072, exp. Sep 2017; lot 6GM082, exp. Sep 2017; lot 6GM088, exp. Oct 2017; lot 6GM087, exp. Oct 2017; lot 6GM198, exp. Oct 2017; lot 6GM081, exp. Sep 2017; lot 6GM091, exp. Oct 2017; lot 6GM199, exp. Oct 2017: INTERNATIONAL: lot 5FA665, exp. April 2017; lot 5GU763, exp. May 2017; lot 6FA293, exp. Oct 2017; lot 6FA292, exp. Oct 2017; lot 6GH294, exp. Oct 2017.
Where was it sold?
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
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 76789| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg recalledEpipen | Meridian Medical Technologies a Pfizer | Other | Nationwide |
More recalls from Meridian Medical Technologies a Pfizer
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg recalledEpipen | Meridian Medical Technologies a Pfizer | Other | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP, 10 mg Automatic, Autoinjector recalledDiazepam | Meridian Medical Technologies a Pfizer | Potency & Assay | Nationwide |
Other Epinephrine recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine | International Medication Systems | Sterility | Nationwide |
| Drug | CLASS II | Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin | Henry Schein Inc. and Glove Club HSI Gloves | Packaging Defects | Nationwide |
| Drug | CLASS II | EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |