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FDA warns against unapproved epinephrine nasal solutions from BPI Labs & Endo USA: what happened, why it matters, and what to do now

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Key takeaways

  • The FDA is warning clinicians not to use two unapproved epinephrine nasal solutions—one made by BPI Labs (Largo, FL) and one by Endo USA (Malvern, PA). These have been confused with FDA-approved injectable epinephrine—creating a risk of accidental IV injection of a non-sterile product. U.S. Food and Drug Administration
  • FDA has logged 25+ confusion reports since 2016, including a 2024 case where the nasal solution was injected. U.S. Food and Drug Administration
  • Endo USA voluntarily recalled all lots of its Adrenalin® Chloride Solution (epinephrine nasal solution) on Dec 20, 2024; FDA later classified it a Class I (most serious) recall on Feb 5, 2025. U.S. Food and Drug AdministrationHMP Global Learning Network
  • BPI Labs has not removed its product from the market despite FDA’s Dec 12, 2024 recall recommendation; FDA subsequently issued a Warning Letter (Mar 20, 2025). U.S. Food and Drug Administration+1
  • These nasal solutions are topical, non-sterile; they must never be injected. U.S. Food and Drug Administration

What the FDA alert actually says

On Jan 16, 2025, the FDA told health care professionals not to use unapproved epinephrine nasal solutions from BPI Labs and Endo USA because they’re being mistaken for injectable epinephrine. The agency emphasized that the nasal products are not sterile, so any IV administration could cause infection in addition to undertreating the patient’s condition. The FDA also highlighted look-alike packaging and similar container-closures as key contributors to the mix-ups. U.S. Food and Drug Administration

Why is the packaging a problem?

For BPI Labs, FDA’s Warning Letter cites misbranding: the firm packaged a non-sterile nasal solution in a vial that looks like a parenteral vial, which “appears identical to containers ordinarily used to package sterile injectable drugs.” That presentation, coupled with labeling issues, contributed to erroneous preparation for injection. U.S. Food and Drug Administration

For Endo USA, the Adrenalin® Chloride Solution (epinephrine nasal solution) label and container closely resembled the company’s Adrenalin® (epinephrine injection) 1 mg/mL—increasing the risk of dangerous confusion. Endo voluntarily recalled all lots within expiry on Dec 20, 2024, later classified by FDA as Class I. U.S. Food and Drug AdministrationHMP Global Learning Network

Timeline at a glance

What these products are—and aren’t

  • They are topical nasal solutions (e.g., ENT/dental vasoconstrictor use), not sterile, not FDA-approved, and never intended for injection. U.S. Food and Drug Administration
  • They are not the same as FDA-approved epinephrine injections (e.g., Adrenalin® injection, EpiPen®, generics).
  • They are not the same as neffy®, the FDA-approved epinephrine nasal spray for treatment of anaphylaxis (2 mg approved Aug 2024; pediatric 1 mg approved Mar 2025). Spray ≠ solution; neffy has its own device, dosing, and labeling. U.S. Food and Drug AdministrationPharmacy Times

Who is at risk?

  • Hospitals and surgery centers stocking both nasal and injectable epinephrine.
  • ENT, dental, and procedural suites where topical vasoconstrictors are used.
  • Supply chains where these products appeared in mainstream distributor catalogs—another factor that normalized their presence.

Real-world harm signals

FDA cites >25 confusion reports since 2016, including a 2024 event where the nasal solution was inadvertently injected. Mixing up a non-sterile topical with a sterile injectable can cause inadequate treatment (e.g., during anaphylaxis or shock) and serious infection. U.S. Food and Drug Administration

Practical actions for hospitals, pharmacies, and clinics

1) Remove & quarantine

  • Endo USA nasal solution: ensure all recalled lots are removed—Endo recalled all lots within expiry on Dec 20, 2024. Follow your recall SOPs. U.S. Food and Drug Administration
  • BPI Labs nasal solution: FDA advises not to use; if any units remain in inventory, quarantine and contact your supplier while monitoring FDA updates (BPI has not recalled as of the FDA alert/letter). U.S. Food and Drug Administration+1

2) Segregate and relabel storage

  • Physically separate topical nasal agents from injectables; avoid co-locating 30 mL vials that look alike. Use auxiliary labels (“TOPICAL—DO NOT INJECT”). U.S. Food and Drug Administration

3) Configure technology safeguards

  • In EHR/ordering systems, add alerts and distinctive names (e.g., “Epinephrine NASAL SOLUTION — NON-STERILE — DO NOT INJECT”).
  • In ADC/barcode systems, block or hard-stop scanning of the nasal solution in areas where injectables are prepared. (These actions implement FDA’s intent to prevent confusion.) U.S. Food and Drug Administration

4) Educate frontline staff

  • Share the FDA alert and your local workflow changes with pharmacists, anesthesia, ENT, ED, ICU, and OR staff. Highlight look-alike risks and the non-sterile status of the nasal solutions. U.S. Food and Drug Administration

5) Standardize treatment kits

  • For anaphylaxis and hypotension algorithms, ensure only sterile injectable epinephrine is stocked; remove any nasal solutions from critical care med trays. (FDA warns the nasal products must never be injected.) U.S. Food and Drug Administration

Regulatory angle: how did unapproved products end up in circulation?

Endo’s press communication (posted on FDA’s site) notes that its nasal solution predates the 1938 FD&C Act and was never submitted for FDA approval, meaning safety and efficacy were never established—a key reason behind the recall. The FDA also deemed the product misbranded due to misleading, look-alike labeling vs. the injectable. U.S. Food and Drug AdministrationPharmTech

For BPI, FDA’s Warning Letter cites both unapproved new drug marketing and misbranding because the container-closure looked like an injection vial and contributed to medication errors. U.S. Food and Drug Administration

Don’t confuse with neffy® (approved epinephrine nasal spray)

In 2024 the FDA approved neffy 2 mg for patients ≥30 kg, and in March 2025 approved neffy 1 mg for certain pediatric patients. Neffy is a device-based nasal spray with clinical data showing pharmacokinetic and hemodynamic comparability to injection—not a multi-dose vial of solution. Different formulation, device, labeling, and indications. U.S. Food and Drug AdministrationPharmacy Times

FAQ

Q: Is any epinephrine nasal solution FDA-approved?
A: No. The two products in FDA’s alert are unapproved and should not be used. The FDA-approved intranasal option is neffy (a spray, not a solution in a vial). U.S. Food and Drug Administration+1

Q: What if our practice uses nasal epinephrine as a topical vasoconstrictor for procedures?
A: FDA advises against using the unapproved nasal solutions given the confusion and safety risks. Work with pharmacy to identify approved alternatives and standardize procurement and labeling to avoid mix-ups. U.S. Food and Drug Administration

Q: Where can I read the official documents?

Bottom line

Treat any epinephrine nasal solution in a vial as high-risk for confusion—and remove it from clinical use. If you need intranasal epinephrine for anaphylaxis, that’s neffy (a device-based spray, FDA-approved). For IV/IM administration, use only sterile, FDA-approved injectable epinephrine. The mix-ups FDA documented are serious and preventable with decisive inventory, labeling, system, and education controls. U.S. Food and Drug Administration+1

Sources

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