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Lower risk Drug recall · FDA · Published February 6, 2024

Mallinckrodt Hospital recalls Terlivaz injection due to temperature issues during shipping

Mallinckrodt Hospital recalls Terlivaz (terlipressin for injection) 0.85mg/vial single-dose vials due to temperature excursions during shipping. Affected lots were distributed by Mallinckrodt Hospital Products Inc. in the US.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0341-2024DrugMallinckrodt Hospital ›
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Contact the company

Recalling firmMallinckrodt Hospital Products Inc.440 Us Highway 22, Ste 302 · Bridgewater, NJ 08807-2477
✎ GovInfoNow plain-language explainer

Mallinckrodt Hospital is recalling Terlivaz (terlipressin for injection) vials that may have been exposed to incorrect temperatures during shipping. This could potentially affect the drug's safety and effectiveness, but the recall does not indicate immediate harm to users. Read more at govinfonow.com/recall/32830-mallinckrodt-hospital-recalls-terlivaz-injection-due-to-temperature-issues-during.

Source Summary by GovInfoNow · govinfonow.com/recall/32830-mallinckrodt-hospital-recalls-terlivaz-injection-due-to-temperature-issues-during · Updated August 18, 2026 · FDA enforcement record: FDA #D-0341-2024

Cite this page

“Mallinckrodt Hospital recalls Terlivaz injection due to temperature issues during shipping.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32830-mallinckrodt-hospital-recalls-terlivaz-injection-due-to-temperature-issues-during. Based on FDA recall #D-0341-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0341-2024%22&limit=1).

The FDA announced on Feb. 6, 2024, that Mallinckrodt Hospital Products Inc. is recalling Terlivaz (terlipressin for injection), 0.85mg/vial, due to current good manufacturing practice deviations involving a temperature excursion from shipping delays. The recall affects 421 vials distributed nationwide.

How to tell if you have it

  • Brand: Mallinckrodt Hospital
  • Product: Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial
  • NDC: 43825-200-01
  • Lot #: 22TRP01-F2
  • Expiration Date: 6/30/2024

The hazard

The recall is due to current good manufacturing practice deviations caused by a temperature excursion resulting from a shipping delay from the manufacturer to the distributor. The affected distributor has been notified.

Context

GovInfoNow's records show Mallinckrodt Hospital Products Inc. had one other recall on record since Aug. 6, 2026, involving Acthar Gel 5mL Vials due to particulate matter hazards. Other recent recalls of similar products include TerSera's Zoladex Implants recall (Aug. 31, 2026), McKesson's UDENYCA Injection recall (Jan. 16, 2026), and McKesson's Gemcitabine Injection recall (June 10, 2026).

How to tell if you have this one

Check for Terlivaz (terlipressin for injection) 0.85mg/vial single-dose vials with lot number 22TRP01-F2, which were distributed by Mallinckrodt Hospital Products Inc. in the US. The expiration date is June 30, 2024.

  • Brand
    Mallinckrodt Hospital
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    USA nationwide
Recall numberProduct, codes & lotsQuantityNDC
D-0340-2024Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1; Lot #: 1564-103, Exp 9/30/20248 vials involved in recall (16,479 vials distributed)63004-8710-1, 63004-8710-2, 63004-8712-1, 63004-8712-4, 63004-8711-1, 63004-8711-4
D-0341-2024Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01; Lot #: 22TRP01-F2, Exp 6/30/2024421 vials involved in this recall (2,448 vials distributed)43825-200-01
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify the lot number on your Terlivaz vial to see if it matches 22TRP01-F2.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 22 days after the firm started it.

1. Firm started the recall: Feb 6, 202412. FDA classified it Class II: Feb 21, 202423. Published in FDA’s Enforcement Report: Feb 28, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0341-2024 (February 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0341-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA