FDA Issues Class I Recall for Adrenalin Chloride Solution Due to Misleading Labeling
A Class I recall has been initiated for Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), distributed by Par Pharmaceutical. The recall affects 44 397 amber glass vials, encompassing all lots within expiry.
The recall stems from concerns that the product’s labeling closely resembles the FDA-approved injectable version of Adrenalin (epinephrine injection, USP), creating a risk of medication errors. Given the potential for serious harm or fatal consequences if administered incorrectly, this recall represents the FDA’s most serious classification. The recall was initiated on December 20, 2024, and remains ongoing.
The recalling firm, ENDO USA, Inc., based in Rochester, Michigan, issued a press release to notify health care providers and the public. The FDA classified the recall as Class I on February 5, 2025, indicating a high risk of serious health consequences. The product was distributed nationwide, raising concerns for hospitals, pharmacies, and health care providers.
Epinephrine is a critical medication used for severe allergic reactions (anaphylaxis), cardiac arrest, and as a vasopressor. While the recalled nasal solution is intended for specific nasal applications, confusion with the injectable form poses a serious risk. Pharmacists must exercise caution in handling epinephrine products and educate staff to prevent administration errors. Prompt removal of the recalled product and vigilant patient safety measures are essential to mitigating potential risks.
