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# Endo Recalls Adrenalin Chloride Solution
- URL: https://www.fdaweb.com/endo-recalls-adrenalin-chloride-solution/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158400

FDA says Endo USA has recalled all lots within expiry of its Adrenalin Chloride Solution (EPINEPHrine nasal solution) 30mg/30mL. An agency [notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal?ref=fdaweb.com) says the product pre-dates the 1938 Federal Food, Drug, and Cosmetic Act and was never submitted for FDA approval. Thus, it is legally considered to be an unapproved new drug for which safety and efficacy have not been established and is therefore subject to recall.

“FDA has determined the product to be misbranded with a misleading label similar in appearance to the FDA-approved drug product Adrenalin (epinephrine injection) also produced by Endo,” the notice says.

Endo has not received reports of adverse events in the last five years, FDA says.