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Epinephrine Injection USP 1 mg/10mL
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DRUG RECALLMODERATE

Epinephrine Injection USP 1 mg/10mL

International Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.

What to do

Do not use this product. Contact your pharmacy or healthcare provider immediately if you have received this medication. Return the product to the pharmacy where it was dispensed.

Recalled
Listed
Updated
Recall No.
D-0483-2026
Agency
FDA
Firm
International Medication Systems Ltd.
Recall ID
98690
Status
ONGOING

Recall at a glance

Quantity recalled
81,520 units

Why it was recalled

International Medication Systems Limited is recalling Epinephrine Injection, USP, 1 mg/10mL (0.1 mg/mL) (NDC 76329-3318-1) due to lack of assurance of sterility. Sterile injectable products that lack sterility assurance pose a risk of serious infection if administered.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

EPINEPHRINE Injection, USP

Strength
1 mg
NDC / UPC
NDC 76329-3318-1

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification