Epinephrine Injection Recalled for Lack of Sterility Assurance
Key Takeaways
- The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of epinephrine injection, USP, 1 mg/10 mL (0.1 mg/mL), involving 81 520 units distributed nationwide and identified as Lot #EA038A5 (Exp. 08/2026).
- The recall was initiated by International Medication Systems Ltd. (Amphastar Pharmaceutical Company) due to lack of assurance of sterility, a quality issue that may cause temporary or medically reversible adverse health consequences.
- Epinephrine injection is a critical emergency medication indicated for anaphylaxis, cardiac arrest, and severe hypotension, commonly used in hospital and emergency care settings.
The FDA has classified a Class II recall for epinephrine injection, USP, 1 mg/10 mL (0.1 mg/mL), a critical emergency medication manufactured by International Medication Systems, Limited, an Amphastar Pharmaceutical Company, based in South El Monte, CA. The recall affects 81 520 units distributed nationwide in the US, specifically Lot #EA038A5, with an expiration date of August 2026. The recall was voluntarily initiated on April 1, 2026.
The recall was prompted by lack of assurance of sterility, a significant concern for injectable medications. Although no contamination has been confirmed, compromised sterility may increase the risk of infection or adverse reactions. The FDA classified the recall as Class II on April 14, 2026, indicating that use of the affected product may result in temporary or medically reversible adverse health consequences, with a low probability of serious harm. The firm notified consignees via letter; no public press release has been issued.
Epinephrine injection is a life-saving adrenergic agonist used in the treatment of anaphylaxis, cardiac arrest, and severe hypotension. It is widely used in emergency departments, hospitals, and critical care settings. Pharmacists and health care providers should immediately identify and quarantine affected lot #EA038A5, ensure removal from clinical use, and coordinate replacement supply to maintain emergency readiness.
Reference
FDA. Enforcement Report. April 15, 2026. Accessed April 16, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
