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Class II · ModerateActive recall

Epinephrine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot Number: EA038A5, Expiration Date: 08/2026.
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byInternational Medication Systems, Limited
Brand nameEPINEPHRINE
Generic nameEPINEPHRINE
Active ingredient(s)EPINEPHRINE
Distributed by / forInternational Medication Systems Ltd.
NDC76329-3318-1
Show the full FDA record
Full product labelEPINEPHRINE 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
Recalling firmInternational Medication Systems Ltd.
DistributionU.S. Nationwide
Quantity81,520 units
Recall initiated2026-04-01
Report date2026-04-22
Recall completed—
Recall numberD-0483-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSouth El Monte CA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.