Elevated risk U.S. Food and Drug Administration

Par Pharmaceutical Adrenalin® Chloride Solution recall: Product is an unapproved drug

Recall published 1+ years ago

Product is an unapproved drug.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
December 20, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Par Pharmaceutical
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)

What the company announced

MALVERN, PA, December 20, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-dates the 1938 Federal Food, Drug & Cosmetic Act, was never submitted for approval by the FDA, and as such, is an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. In addition, FDA has determined the product to be misbranded with a misleading label similar in appearance to the FDA-approved drug product Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial, also produced by Endo USA, Inc.

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.

Risk Statement: Intravenous administration of the unapproved non-sterile topical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP), instead of the approved sterile Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial for injection, would result in non-fatal serious and/or severe, health outcomes related to delayed or inadequate treatment of the underlying condition (anaphylaxis, hemodynamic instability, hypotension) or infection due to intravenous administration of a non-sterile product. In addition, there is a high probability that intravenous administration of the nasal product will result in patients receiving the wrong dose of epinephrine in emergency situations for serious, life-threatening conditions such as the treatment of anaphylaxis, blood pressure support, and cardiac arrest. If these events are not treated with the correct dose of epinephrine, patients may be at risk for death.

Endo has not received reports of adverse events in the last five years.

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.

This recall impacts the following product lots:

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

Package Identification: See example of vial label from the affected lots attached to this press release.

Endo is providing written notification to all direct customer accounts that have received the affected product lots and is arranging for return of all existing inventory through Inmar, Inc. Wholesale distributors that have the product lots being recalled should immediately discontinue use and stop distribution immediately.

Questions regarding this recall can be directed to Inmar, Inc. at 1-877-560-8453 Monday through Friday between the hours of 9 a.m. and 5 p.m. EST or by email at [email protected] . For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements including but not limited to any statements related to product recalls, mislabeling, misbranding, safety concerns, administration errors, adverse events, FDA or other regulatory actions and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of risks, uncertainties and factors, including risks and uncertainties related to the recall and any future recalls, potential adverse events and any regulatory actions by the FDA. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with its Form S-1/A.

Customers: Media:

Inmar, Inc. Linda Huss

1-877-560-8453 [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 82809

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 03/2026

NDC number

On the carton and again on the bottle or blister label.

  • 42023-103-01

Model or item number

On the rating label, the box or the instruction sheet.

  • 79637
  • 77776
  • 74716
  • 71835
  • 72916

Package size

Match the net weight or the piece count on the front of the pack.

  • 30 mg
  • 30 mL
  • 1 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Par Pharmaceutical — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Remedy named in the notice: Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with its Form S-1/A.

Company contact: Endo, Inc. — Consumers: Inmar, Inc., 1-877-560-8453 — Media: Linda Huss, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Par Pharmaceutical prescription & otc drugs recalled?

Product is an unapproved drug. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 82809; best-by date 03/2026; model number 79637, 77776, 74716. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The notice says: Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with its Form S-1/A.

Where was the recalled product sold?

It was distributed nationwide.

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