The FDA enforcement report lists a Class I recall, dated 16 September 2026, of epinephrine injection 30 mg per 30 mL (1 mg per mL) in 30 mL multiple-dose vials from American Regent. The stated reasons are particulate matter and lack of assurance of sterility. The particles were identified as nylon, cellulose, acrylic, polyethylene and glass, and some vials were broken or leaking. The status is ongoing.
Class I is the FDA's most serious recall category. The record does not give lot numbers or say whether any patient was harmed, and it does not describe other epinephrine products.
If you hold this product, quarantine it and check the lot numbers against the FDA notice. Whether the product is in use in India, and CDSCO's position, are not stated in the source.
- FDA Class I recall dated 16 September 2026 of 30 mL multi-dose epinephrine vials from American Regent.
- Reasons given: particulate matter, broken and leaking vials, and lack of assurance of sterility.
- Check stock and lot numbers against the FDA notice and quarantine affected vials.
- Inspect any vial for particles and damage before drawing up.
- CDSCO status and distribution in India are not given in the source.
Why it matters
Epinephrine stock sits in resuscitation trolleys and is used in emergencies when no one checks it.
Don't overread it
The recall concerns one manufacturer's product and is not a safety finding about epinephrine itself.
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