FDA recall D-0483-2026

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

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-04-01

Report date

2026-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

South El Monte, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0483-2026