FDA record · warning letter

FDA warning letter: New Life Pharma LLC (Apr 14, 2026)

On Apr 14, 2026, FDA issued a warning letter to New Life Pharma LLC of Northvale, NJ under the subject "CGMP/Adulterated and Unapproved New Drug/Misbranded". It names semaglutide, tirzepatide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to New Life Pharma LLC
Field	What FDA’s record states	Source
Recipient	New Life Pharma LLC	FDA letter
Location	Northvale, NJ	FDA letter
Letter date	Apr 14, 2026	FDA letter
Posted by FDA	Apr 21, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	CGMP/Adulterated and Unapproved New Drug/Misbranded	FDA letter
MARCS-CMS number	725661	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). These products are misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o) because you did not properly register you firm or list your drugs with FDA.”FDA warning letter to New Life Pharma LLC, Apr 14, 2026 · read the full letter on fda.gov ↗

What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.

Source

Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters