Adrenalin Chloride Solution (Epinephrine Nasal Solution recall
FDA recall D-0223-2025 · initiated Dec 20, 2024
ENDO USA, Inc. recalled Adrenalin Chloride Solution (Epinephrine Nasal Solution in Dec 2024 — an FDA Class I recall (D-0223-2025) because Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP).
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 44,397 amber glass vials
Details
- Product
- 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
- Recalling company
- Endo Pharms
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Dec 20, 2024
- FDA report date
- Feb 12, 2025
Frequently asked
- Was Adrenalin Chloride Solution (Epinephrine Nasal Solution recalled?
- ENDO USA, Inc. recalled Adrenalin Chloride Solution (Epinephrine Nasal Solution in Dec 2024 — an FDA Class I recall (D-0223-2025) because Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP). Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Adrenalin Chloride Solution (Epinephrine Nasal Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0223-2025 was: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
- Is a recalled Adrenalin Chloride Solution (Epinephrine Nasal Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Adrenalin Chloride Solution (Epinephrine Nasal Solution are affected?
- Distributed: USA nationwide.. The recall covers these lots — All lots within expiry. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0223-2025.