ENDO Recalls Adrenalin Chloride Vials Due to Misleading Label
ENDO USA recalls 44,397 vials of Adrenalin Chloride Solution because the label is misleading and resembles FDA-approved Epinephrine Injection.
Stop using this now
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
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What happened, in plain English
ENDO USA, Inc. has recalled Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) distributed by Par Pharmaceutical. The issue stems from a labeling error where the product's appearance is similar to the FDA-approved drug product Adrenalin (epinephrine injection, USP). This confusion could lead to serious medication errors. Read more at govinfonow.com/recall/32349-endo-recalls-adrenalin-chloride-vials-due-to-misleading-label.
Source Summary by GovInfoNow · govinfonow.com/recall/32349-endo-recalls-adrenalin-chloride-vials-due-to-misleading-label · Updated October 9, 2026 · FDA enforcement record: FDA #D-0223-2025
Cite this page
“ENDO Recalls Adrenalin Chloride Vials Due to Misleading Label.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32349-endo-recalls-adrenalin-chloride-vials-due-to-misleading-label. Based on FDA recall #D-0223-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0223-2025%22&limit=1).
Why it’s dangerous
The primary danger is medication confusion. Because the label is misleadingly similar to the FDA-approved Adrenalin injection, users may incorrectly assume the products are interchangeable. Using a nasal solution when an injection is required, or vice versa, can result in improper dosing and treatment failure.
Who’s affected
Patients or healthcare providers who have purchased or administered this specific nasal solution distributed nationwide. The risk is highest for anyone who might mistake the nasal spray for an injectable epinephrine product due to the similar labeling.
How to tell if you have this one
Look for amber glass vials containing Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL). The product is distributed by Par Pharmaceutical in Chestnut Ridge, NY, with NDC 42023-103-01. All lots within the expiry date are included in this recall.
- Brand
ENDO USA- Category
Drug
What to do — step by step
Stop using the product
Do not use the recalled Adrenalin Chloride Solution vials due to the risk of medication error from misleading labeling.
Return or discard the item
The record does not specify a return process or remedy details, so contact your pharmacy or healthcare provider for guidance on disposal or replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0223-2025 (December 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0223-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.