Epinephrine recalls: 14 FDA reports
Recalls involving Epinephrine. What was wrong with each batch, and how the FDA graded the risk.
14Reports
2Class I
4Ongoing
2026-06-17Most recent
2 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC
D-0581-2026 · Class III · reported 2026-06-17 · Ongoing
- Why it was recalled
- Failed Impurities/Degradations Specifications
- Product
- Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
- Where it went
- US Nationwide.
- How much
- 898,050 vials
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL
D-0483-2026 · Class II · reported 2026-04-22 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
- Where it went
- U.S. Nationwide
- How much
- 81,520 units
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 S
D-0342-2024 · Class II · reported 2024-02-28 · Completed
- Why it was recalled
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
- Product
- Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
- Where it went
- USA nationwide.
- How much
- 1,099 Single Dose Vials
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan
D-1013-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-102-02
- Where it went
- USA nationwide.
- How much
- 55 packs
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Myla
D-1014-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02
- Where it went
- USA nationwide.
- How much
- 30 packs
EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton
D-1012-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02
- Where it went
- USA nationwide.
- How much
- 4 cartons/2 auto injectors each
EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Myla
D-0993-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
- Where it went
- USA nationwide.
- How much
- 5 cartons
Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharm
D-1022-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01
- Where it went
- USA nationwide.
- How much
- 58 cartons
EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors a
D-0578-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27
- Where it went
- FL, GA, SC
- How much
- 1776 boxes
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty
D-0528-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01
- Where it went
- FL, GA, SC
- How much
- 620 injector
EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and
D-0577-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27
- Where it went
- FL, GA, SC
- How much
- 414 boxes
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured fo
D-1260-2020 · Class II · reported 2020-05-13 · Terminated
- Why it was recalled
- CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
- Product
- Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
- Where it went
- Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.
- How much
- 600 cartons/2 auto-injector per carton
Class I
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown W
D-0690-2017 · Class I · reported 2017-05-10 · Ongoing
- Why it was recalled
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Product
- 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 went
- 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.
- How much
- 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)
Class I
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgant
D-0691-2017 · Class I · reported 2017-05-10 · Ongoing
- Why it was recalled
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Product
- EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 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 Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
- Where it went
- 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.
- How much
- 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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