EPINEPHRINE

Generic: EPINEPHRINE

Amneal Pharmaceuticals Private LimitedManufacturer
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRoute
EPINEPHRINEActive Substance
2025-12-08Original Approval

EPINEPHRINE is FDA application ANDA218208, sponsored by AMNEAL. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2023-03-16
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufacture

Labeling; Incorrect NDC number on outer carton of product.

Class II2026-04-01
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA

Lack of Assurance of Sterility

Class II2022-04-13
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, N

cGMP deviations: Temperature abuse

Class I2026-08-11
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramusc

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as

Class II2022-04-13
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma

cGMP deviations: Temperature abuse

Class III2026-05-14
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696

Failed Impurities/Degradations Specifications

Class II2020-03-05
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pha

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed

Class II2021-03-15
EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Train

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class II2021-03-15
EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DRUG INEFFECTIVE
4,661 reports
2
HEADACHE
3,025 reports
3
SINUSITIS
2,894 reports
4
PRODUCT DOSE OMISSION ISSUE
2,756 reports
5
FATIGUE
2,742 reports
6
PAIN
2,477 reports
7
COVID-19
2,417 reports
8
DYSPNOEA
2,219 reports
9
NAUSEA
2,189 reports
10
PNEUMONIA
2,057 reports