CLASS I ONGOING Drug recall · Reported 12 Feb 2025 · FDA Enforcement Report
Adrenalin Chloride Solution (Epinephrine Nasal Solution recalled
Endo USA is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/ (1mg/mL), distributed nationwide in the US. The recall was initiated on 20 Dec 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0223-2025
- FDA event ID
- 96013
- Recalling firm
- Endo USA, Rochester, MI
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 5 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Nasal Sprays
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 5 Feb 2025 | Classified by FDA | +47 days |
| 12 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Which lots are affected?
All lots within expiry
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Endo USA
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride | Endo USA | Other | Nationwide |
| Drug | CLASS III | Everolimus tablets 5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 10 mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 2.5 mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Everolimus tablets 7.5mg (each carton contains 4 blister recalled | Endo USA | Potency & Assay | Nationwide |