CLASS II Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report

Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection recalled

Innoveix Pharmaceuticals is recalling Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, distributed nationwide in the US. The recall was initiated on 10 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20

Quantity recalled3905 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0157-2020
FDA event ID: 84006
Recalling firm: Innoveix Pharmaceuticals, Addison, TX
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2019
FDA classified: 28 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

10 Oct 2019	Recall initiated by company
28 Oct 2019	Classified by FDA	+18 days
6 Nov 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Sterility Assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Lack of Sterility Assurance.

Which lots are affected?

Lot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 84006

This product is part of a recall event; the main page for the event is Lyophilized Human Chorionic Gonadotropin 5,500 USP Units recalled.

Reported	Class	Recall	Company	Reason	Where
6 Nov 2019	CLASS II	Lyophilized Human Chorionic Gonadotropin 5,500 USP Units recalled	Innoveix Pharmaceuticals	Sterility	Nationwide
6 Nov 2019	CLASS II	Lyophilized Sermorelin w/ GHRP2 3 mg For injection recalled	Innoveix Pharmaceuticals	Sterility	Nationwide
6 Nov 2019	CLASS II	Lyophilized Human Chorionic Gonadotropin 5,000 USP Units recalled	Innoveix Pharmaceuticals	Sterility	Nationwide

More recalls from Innoveix Pharmaceuticals

All 6

Reported	Class	Recall	Company	Reason	Where
28 Jul 2021Drug	CLASS II	Compounded Lyophilized AOD recalled by Innoveix Pharmaceuticals	Innoveix Pharmaceuticals	Sterility	Nationwide
28 Jul 2021Drug	CLASS II	Compounded Lyophilized Semorelin/Ipamorelin 3 mg recalled	Innoveix Pharmaceuticals	Sterility	Nationwide
6 Nov 2019Drug	CLASS II	Lyophilized Human Chorionic Gonadotropin 5,000 USP Units recalled	Innoveix Pharmaceuticals	Sterility	Nationwide
6 Nov 2019Drug	CLASS II	Lyophilized Sermorelin w/ GHRP2 3 mg For injection recalled	Innoveix Pharmaceuticals	Sterility	Nationwide
6 Nov 2019Drug	CLASS II	Lyophilized Human Chorionic Gonadotropin 5,500 USP Units recalled	Innoveix Pharmaceuticals	Sterility	Nationwide