ENDO USA recalls Adrenalin Chloride Solution (Epine: 30mg/30mL vials) due to misleading label similar to FDA-approved epinephrine injection. Consumers should check product details and contact for guidance.
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
ENDO USA is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution) because its label resembles FDA-approved epinephrine injection. This could cause confusion with a different medication, potentially leading to incorrect use.
The label design is similar to FDA-approved epinephrine injection, which could lead to confusion. This might cause someone to use the wrong medication in an emergency, but the risk is low since it's a nasal solution, not an injection.
People who own or use Adrenalin Chloride Solution (Epinephrine Nasal Solution) vials. Those most at risk are individuals who might mistake this product for the FDA-approved epinephrine injection.
Check for Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) 30mg/30mL vials. The product was distributed by Par Pharmaceutical with NDC 42023-103-01 and all lots within expiry.
Verify the product label matches the description: Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) 30mg/30mL vials with NDC 42023-103-01.
The recall is due to label similarity, not safety issues. If used correctly, it should be safe.
Look for Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) 30mg/30mL vials with NDC 42023-103-01.
No action is required if you have the product but it's used correctly. The recall is for label confusion, not safety.
We’ve drafted a message you can send ENDO USA to request your refund or repair — edit it as you like.
Subject: Recall D-0223-2025 — ENDO USA ENDO USA Hello, I own a ENDO USA that is covered by recall D-0223-2025 from ENDO USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
