Recall archive / FDA company announcement

Par Pharmaceutical: Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) — FDA announcement Dec 20, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Dec 20, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)
Reason: Product is an unapproved drug.
Classification: Not supplied
Recalling firm: Endo, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: edffe4c3340dc0fd

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Both products are distributed to hospitals and healthcare systems for use by healthcare professionals. The similarity in labeling makes it difficult to distinguish between the non-sterile topical and sterile injectable product which can lead to potential administration errors. This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial.; Product \| NDC \| Lot # \| Date of Expiry; Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application 30mg/30mL (1mg/mL) \| 42023-103-01 \| 82809 \| 03/2026; 79637 \| 11/2025; 77776 \| 07/2025; 74716 \| 05/2025; 71835 \| 01/2025; 72916 \| 01/2025

Label field

Details supplied by the agency

Lot, code or applicability

Both products are distributed to hospitals and healthcare systems for use by healthcare professionals. The similarity in labeling makes it difficult to distinguish between the non-sterile topical and sterile injectable product which can lead to potential administration errors. This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial.; Product | NDC | Lot # | Date of Expiry; Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application 30mg/30mL (1mg/mL) | 42023-103-01 | 82809 | 03/2026; 79637 | 11/2025; 77776 | 07/2025; 74716 | 05/2025; 71835 | 01/2025; 72916 | 01/2025

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product	NDC	Lot #	Date of Expiry
Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application 30mg/30mL (1mg/mL)	42023-103-01	82809	03/2026
		79637	11/2025
		77776	07/2025
		74716	05/2025
		71835	01/2025
		72916	01/2025

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) is a vasoconstrictor for topical application. The 30 mL vial is distributed in individually packed cartons under NDC #42023-103-01 with the language “Nasal Solution USP” and “For Topical Application” on the package. The product lots being recalled were distributed nationwide to wholesale distributors from October 10, 2023, through December 11, 2024.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Dec 20, 2024
Company announcement date: Dec 20, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.