Terlipressin recalls

The FDA has published 1 recall involving Terlipressin since 2024. The latest was reported on 28 Feb 2024. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2024

Last 12 months0reported

Class I00% of total

Ongoing1latest 28 Feb 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why terlipressin is recalled

Manufacturing (CGMP) Deviations1100%

Companies

Mallinckrodt Hospital Products1100%

By year

20241100%

Ongoing terlipressin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
28 Feb 2024Drug	CLASS II	Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial recalledTerlivaz	Mallinckrodt Hospital Products	Manufacturing (CGMP) Deviations	Nationwide

All terlipressin recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
28 Feb 2024Drug	CLASS II	Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial recalledTerlivaz	Mallinckrodt Hospital Products	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Terlipressin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.