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Class I · Most seriousActive recall

Adrenalin Chloride Solution (Epinephrine Nasal Solution

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberAll lots within expiry
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forPar Pharmaceutical, Chestnut Ridge, NY 10977
NDC42023-103-01
Show the full FDA record
Full product labelAdrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Recalling firmENDO USA, Inc.
DistributionUSA nationwide.
Quantity44,397 amber glass vials
Recall initiated2024-12-20
Report date2025-02-12
Recall completed
Recall numberD-0223-2025
ClassificationClass I
FDA statusOngoing
Origin on fileRochester MI United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.