CLASS II ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalled
International Medication Systems is recalling Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL), distributed nationwide in the US. The recall was initiated on 1 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0483-2026
- FDA event ID
- 98690
- Recalling firm
- International Medication Systems, South El Monte, CA
- Brand
- Epinephrine
- Manufacturer
- International Medication Systems, Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2026
- FDA classified
- 14 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 1 Apr 2026 | Recall initiated by company | |
| 14 Apr 2026 | Classified by FDA | +13 days |
| 22 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot Number: EA038A5, Expiration Date: 08/2026.
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Epinephrine recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin | Henry Schein Inc. and Glove Club HSI Gloves | Packaging Defects | Nationwide |
| Drug | CLASS II | EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | EPINEPHrine 8mg/ added to dextrose 5%, 32 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |