FDA Recall D-0223-2025

ENDO USA, Inc. · Rochester, MI

Class I — life-threatening Ongoing 510 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: All lots within expiry

Quantity: 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)

Recall record

Recall number: D-0223-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: USA nationwide.
Recall initiated: 2024-12-20
Classified by FDA Center: 2025-02-05
FDA published: 2025-02-12
Recalling firm: ENDO USA, Inc.
Firm location: Rochester, MI

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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