Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed
Summary
The FDA issued a Class I for Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL by ENDO USA, Inc.. Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP).
Details
Source
Drug Recall
External ID
D-0223-2025
Action Date
2025-02-12
Status
Ongoing
Category
drug
Product Description
Adrenalin 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
Lot/Code Info: All lots within expiry
Quantity Affected: 44,397 amber glass vials
Reason for Recall
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-20
Company
Rochester, MI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ENDO USA, Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ENDO USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ENDO USA, Inc. have FDA actions?
ENDO USA, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0223-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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