FDA Drugs recall ·
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only… recall
- Recall number
- D-0483-2026
- Date
- (initiated April 1, 2026)
- Company / brand
- International Medication Systems Ltd.
1886 Santa Anita Ave, South El Monte, CA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 81,520 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Number: EA038A5, Expiration Date: 08/2026.
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0483-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.