RecallRadar

FDA Drug recall D-0692-2021

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX…

On 2021-07-28 the FDA classified a Class II recall of Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX… by Innoveix Pharmaceuticals, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0692-2021
ClassificationClass II
Statuscompleted
Initiated2021-07-09
Published2021-07-28
Last updated2026-09-13 11:52 UTC
CompanyInnoveix Pharmaceuticals
DistributionUS

Product

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0692-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.