Unrated Drug recall · FDA · Published April 1, 2026

EPINEPHR: Sterility Risk in 1 mg/10mL Injection Recall

Recall of EPINEPHRINE Injection (1 mg/10mL) due to lack of sterility assurance. Affected lots from International Medication Systems, Ltd. in EL Monte, CA. No remedy specified in official notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0483-2026Drug International Medication Systems ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmInternational Medication Systems Ltd.1886 Santa Anita Ave · South El Monte, CA 91733-3414

✎ GovInfoNow plain-language explainer

International Medication Systems recalls a specific epinephrine injection product because it may not be sterile. This could lead to infections if used improperly. The recall affects medical users who have this product. Read more at govinfonow.com/recall/31376-epinephr-sterility-risk-in-1-mg-10ml-injection-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/31376-epinephr-sterility-risk-in-1-mg-10ml-injection-recall · Updated August 17, 2026 · FDA enforcement record: FDA #D-0483-2026

Cite this page

“EPINEPHR: Sterility Risk in 1 mg/10mL Injection Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31376-epinephr-sterility-risk-in-1-mg-10ml-injection-recall. Based on FDA recall #D-0483-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0483-2026%22&limit=1).

The FDA announced on April 1, 2026, that International Medication Systems Ltd. is recalling Epinephrine Injection, USP due to a lack of assurance of sterility. The voluntary Class II recall affects 81,520 units distributed nationwide.

How to tell if you have it

Brand: International Medication Systems
Product: EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only
NDC: 76329-3318-1
Lot Number: EA038A5
Expiration Date: 08/2026

The hazard

The recall addresses a lack of assurance of sterility in the affected epinephrine injection units. The FDA record does not report specific incidents or injuries associated with this recall.

Context

GovInfoNow's records show other recent recalls of similar products include Reliance Pemetrexed Injection Recall: Sterility Risk in IV Doses (2026-06-24) and American Regent Epinephrine Injection Recall: Particulate Matter Risk (2026-08-11). Additional recent recalls of similar products include Reliance Pemetrexed Injection Recall: Lack of Sterility Risk (2026-06-24).

How to tell if you have this one

Check for the lot number EA038A5 on the product label. The product was sold by International Medication Systems, Ltd. in EL Monte, CA with expiration date 08/2026.

Brand
International Medication Systems
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for lot number EA038A5 and expiration date 08/2026 on the injection vial.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Apr 1, 2026Firm started the recall
Apr 14, 2026FDA classified it Class II
Apr 22, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31376-epinephr-sterility-risk-in-1-mg-10ml-injection-recall">EPINEPHR: Sterility Risk in 1 mg/10mL Injection Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0483-2026 (April 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0483-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.