FDA recall, , Moderate risk
International Medication Systems Epinephrine Injection
Epinephrine Injection lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
International Medication Systems Ltd., of South El Monte, California, recalled EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, due to a lack of assurance of sterility. The recall, which began April 1, 2026, involved 81,520 units distributed nationwide. The FDA added the recall to its Enforcement Report on April 14, 2026, and it was included in the weekly enforcement report on April 22, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL)
- NDC
- 76329-3318-1
- Lot code
- EA038A5
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- International Medication Systems Ltd.South El Monte, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98690
- Recall number
- D-0483-2026
- Quantity recalled
- 81,520 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
