FDA WARNING_LETTER - BPI Labs LLC - March 25, 2025

On March 20, 2025, the FDA issued a Warning Letter to BPI Labs, LLC (BPI’s) regarding their Epinephrine Chloride Nasal Solution 1 mg/mL, 10 mL. The FDA determined this product is an unapproved new drug and is misbranded.

The Epinephrine Chloride Nasal Solution is considered a "new drug" because it is not generally recognized as safe and effective (GRASE) for its intended use as a nasal decongestant/vasoconstrictor. No FDA-approved applications are in effect for this product, violating sections 505(a) and 301(d) of the FD&C Act.

Furthermore, the product is misbranded under section 502(i)(1) of the FD&C Act. The container closure system for the nasal solution is identical to BPI’s FDA-approved epinephrine injection product, a glass vial typically used for sterile injectable drugs. This similarity may mislead users into believing the product is for injection, increasing the risk of erroneous administration. The FDA has received reports of such confusion.

BPI Labs is required to notify the FDA in writing within fifteen working days of receipt of the letter, detailing specific steps taken to address these violations, prevent recurrence, and provide supporting documentation. Failure to adequately address these issues may result in legal action, including seizure and injunction.