FDA Recall D-0483-2026
International Medication Systems Ltd. · South El Monte, CA
Class II Ongoing 43 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0483-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2026-04-01
- Classified by FDA Center
- 2026-04-14
- FDA published
- 2026-04-22
- Recalling firm
- International Medication Systems Ltd.
- Firm location
- South El Monte, CA
Drug identification
- Brand name(s)
- EPINEPHRINE
- Generic name(s)
- EPINEPHRINE
- Manufacturer(s)
- International Medication Systems, Limited
- NDC(s)
76329-3318- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.