Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Malvern, PA – Endo USA, Inc., a subsidiary of Endo International, has announced a voluntary nationwide recall of all lots of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, due to concerns about potential administration errors. The recall involves a non-sterile topical product that could lead to serious health risks if incorrectly administered intravenously.
This recall affects all Adrenalin® Chloride Solution lots that remain within their expiration dates and were distributed to wholesale distributors nationwide between October 10, 2023, and December 11, 2024. The product, which was never submitted for approval by the FDA, is an unapproved drug. The FDA has also determined the product to be misbranded, with labeling that closely resembles the FDA-approved version of Adrenalin® (epinephrine injection, USP), a sterile injectable used to treat anaphylaxis, cardiac arrest, and other life-threatening conditions.
This recall impacts the following product lots:
| 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 |
Risk of Serious Administration Errors
The product’s mislabeling, which includes similar packaging to the approved Adrenalin® injection, could lead to critical errors in administering the wrong formulation. The unapproved nasal solution is a non-sterile topical vasoconstrictor intended for nasal application, but its packaging is so similar to the injectable version that healthcare professionals may mistakenly administer it intravenously.
Intravenous injection of the non-sterile nasal solution could lead to severe or life-threatening consequences, including delayed treatment of anaphylaxis, hypotension, and hemodynamic instability, as well as potential infection due to the use of a non-sterile product. In emergency situations, such as the treatment of anaphylaxis or cardiac arrest, receiving an incorrect dose of epinephrine could increase the risk of severe health outcomes, including death.
Although no adverse events have been reported over the last five years, Endo has decided to recall the product as a precautionary measure to protect patient safety.
The recalled Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) comes in 30 mL vials labeled with “Nasal Solution USP” and “For Topical Application” on the package. It was distributed under NDC 42023-103-01. Only the unapproved nasal solution is affected by this recall. The approved injectable Adrenalin® (epinephrine injection, USP) is not part of this recall.
Endo is contacting all direct customer accounts that received the affected lots and is working with Inmar, Inc. to facilitate the return of all existing inventory. Healthcare providers who have received the recalled product are advised to discontinue its use immediately and stop further distribution.
Steps for Consumers and Healthcare Providers
Affected healthcare providers and wholesalers are urged to stop using the recalled product and return any remaining inventory to Inmar, Inc. The company is providing written notifications to customers, along with instructions on returning the product.
For more information or to arrange the return of the product, customers can contact Inmar, Inc. at 1-877-560-8453, Monday through Friday from 9 a.m. to 5 p.m. EST, or by email at rxrecalls@inmar.com. Healthcare professionals seeking medical or technical product information, or who wish to report a product complaint or adverse event, can call 1-800-828-9393.
Healthcare professionals and consumers are encouraged to report any adverse events or quality issues associated with this product to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, or by fax. For more information, visit the FDA’s website or contact the MedWatch program at 1-800-FDA-1088.
This press release contains forward-looking statements regarding the recall, product safety concerns, and regulatory actions. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ. Endo does not assume any obligation to update these statements except as required by applicable securities laws.
