FDA-Drug2026-04-22Class IIPROCESSING DEFECT
International Medication Systems epinephrine injection recalled for sterility concerns
What this means
International Medication Systems Ltd. is recalling one lot of epinephrine injection due to concerns that the sterility of the product cannot be assured. The affected lot (EA038A5, expiring 08/2026) was distributed nationwide. No injuries have been reported.
- Stop using epinephrine injection lot EA038A5 immediately
- Contact your pharmacy or healthcare provider if you have this lot
- Do not use this medication; contact FDA or the manufacturer for instructions on safe disposal
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
81,520 units
Manufactured in
1886 Santa Anita Ave, N/A, South El Monte, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0483-2026Want us to check the next one for you?
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