CLASS II Drug recall · Reported 27 Apr 2022 · FDA Enforcement Report

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL Injection vials recalled

North American Custom Laboratories is recalling Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL Injection vials, distributed nationwide in the US. The recall was initiated on 5 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 32961 BUD: 5/12/2022

Quantity recalled189 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-0777-2022
FDA event ID: 89954
Recalling firm: North American Custom Laboratories, Richardson, TX
Classification: Class II
Status: Terminated
Recall initiated: 5 Apr 2022
FDA classified: 21 Apr 2022
Reported: 27 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

5 Apr 2022	Recall initiated by company
21 Apr 2022	Classified by FDA	+16 days
27 Apr 2022	Published in enforcement report	+6 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 Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

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

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

Where it was distributed

Nationwide within United States

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Which lots are affected?

Lot #: 32961 BUD: 5/12/2022

Where was it sold?

Nationwide within 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

6 other products · FDA event 89954

This product is part of a recall event; the main page for the event is PT-141 (Bremelanotide Acetate) 10 mg/mL Injection vials recalled.

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022	CLASS II	PT-141 (Bremelanotide Acetate) 10 mg/mL Injection vials recalled	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022	CLASS II	ARA-290 (Cibinetide Acetate) 6 mg/mL Injection vials recalled	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022	CLASS II	Melanotan II 1 mg/mL Injection vials recalled by North American Custom	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022	CLASS II	Sermorelin Acetate 1 mg/mL Injection vials recalled	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022	CLASS II	BPC-157 2 mg/mL Injection vials recalled by North American Custom	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022	CLASS II	LL-37 2 mg/mL Injection vials recalled by North American Custom	North American Custom Laboratories	Sterility	Nationwide

More recalls from North American Custom Laboratories

All 7

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022Drug	CLASS II	LL-37 2 mg/mL Injection vials recalled by North American Custom	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022Drug	CLASS II	BPC-157 2 mg/mL Injection vials recalled by North American Custom	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022Drug	CLASS II	Sermorelin Acetate 1 mg/mL Injection vials recalled	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022Drug	CLASS II	Melanotan II 1 mg/mL Injection vials recalled by North American Custom	North American Custom Laboratories	Sterility	Nationwide
27 Apr 2022Drug	CLASS II	ARA-290 (Cibinetide Acetate) 6 mg/mL Injection vials recalled	North American Custom Laboratories	Sterility	Nationwide

Other Ipamorelin recalls

All 6

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Drug	CLASS II	Ipamorelin, 2000 MCG/ML vial recalled by Advanced Nutriceuticals	Advanced Nutriceuticals	Sterility	7 states
22 Jan 2020Drug	CLASS II	Ipamorelin 2000MCG/ML INJ in vial Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
19 Jun 2019Drug	CLASS II	Ipamorelin Acetate 9 mg/ Injectable vials recalled by Pharm D Solutions	Pharm D Solutions	Sterility	Nationwide
20 Feb 2019Drug	CLASS II	Ipamorelin, 15mg, injection recalled by Promise Pharmacy	Promise Pharmacy	Sterility	Nationwide
20 Feb 2019Drug	CLASS II	Ipamorelin, 9 mg injection recalled by Promise Pharmacy	Promise Pharmacy	Sterility	Nationwide